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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Excella Gmbh

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ACICLOVIR

ACYCLOVIR SODIUM

ADAPALENE

ALFUZOSIN HYDROCHLORIDE

ANASTROZOLE

ATOVAQUONE

AZATHIOPRINE

BACLOFEN

BICALUTAMIDE

BICALUTAMIDE MILLED Z

BISOPROLOL HEMIFUMARATE

BUPIVACAINE (S) HYDROCHLORIDE

BUSPIRONE HYDROCHLORIDE

BUSULFAN

Benzbromarone

Bupivacaine Hydrochloride

CEVIMELINE HYDROCHLORIDE

Capecitabine

DEFEROXAMINE MESYLATE

DEFEROXAMINE MESYLATE USP

DICLOFENAC SODIUM

DOXAZOSIN MESYLATE

Dobutamine hydrochloride

ENALAPRILAT

EPINASTINE HYDROCHLORIDE

Enalapril maleate

Estramustine Phosphate Sodium

FLUNIXIN MEGLUMINE

FLUTAMIDE

GANCICLOVIR

GANCICLOVIR ANHYDROUS R

GANCICLOVIR SODIUM

HALOPERIDOL

HALOPERIDOL DECANOATE

LANTHANUM CARBONATE

LEVOTHYROXINE SODIUM

Levomilnacipran Hydrochloride

MASITINIB MESYLATE

METHOTREXATE

METHOTREXATE SODIUM

MYCOPHENOLATE MOFETIL

MYCOPHENOLATE MOFETIL SIEVED

MYCOPHENOLATE SODIUM

Methotrexate

Mianserin hydrochloride

R-BACLOFEN

RALOXIFENE HYDROCHLORIDE

RIVASTIGMINE TARTRATE

ROPIVACAINE HYDROCHLORIDE

Rivastigmine

TAMOXIFEN CITRATE

TEMOZOLOMIDE

TIMOLOL HEMIHYDRATE

TIMOLOL MALEATE

TRAMADOL HYDROCHLORIDE

TRAZODONE HYDROCHLORIDE

Tilidine hydrochloride hemihydrate

deracoxib

firocoxib

l-Baclofen

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Status - Active

Status - Inactive

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EXPIRED

VALID

WITHDRAWN BY HOLDER

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218MF10433

219MF10207

219MF10242

219MF10360

220MF10049

220MF10219

220MF10252

220MF10253

221MF10041

221MF10277

222MF10059

222MF10240

222MF10281

223MF10158

225MF10210

228MF10131

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ACICLOVIR
Issue/Submission Date
1994-01-10
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
ACICLOVIR
Issue/Submission Date
1994-01-10
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ACYCLOVIR SODIUM
Issue/Submission Date
1994-06-09
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Aciclovir
Issue/Submission Date
2016-12-15
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Filing Details
ACYCLOVIR SODIUM
Aciclovir
Issue/Submission Date
1994-06-09
2016-12-15
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ADAPALENE
Issue/Submission Date
2006-02-09
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Adapalene at NUERNBERGER STRASSE 12...
Issue/Submission Date
2016-07-20
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
ADAPALENE
Adapalene at NUERNBERGER STRASSE 12...
Issue/Submission Date
2006-02-09
2016-07-20
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ALFUZOSIN HYDROCHLORIDE
Issue/Submission Date
2004-08-24
CEP/COS

Application Number
Status
VALID
Filing Details
Alfuzosin hydrochloride
Issue/Submission Date
2017-03-29
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
ALFUZOSIN HYDROCHLORIDE
Alfuzosin hydrochloride
Issue/Submission Date
2004-08-24
2017-03-29
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ANASTROZOLE
Issue/Submission Date
2007-03-09
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Anastrozole Micronised (Z), milled ...
Issue/Submission Date
2019-01-25
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Anastrozole at NUERNBERGER STRASSE ...
Issue/Submission Date
2010-10-13
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Filing Details
ANASTROZOLE
Anastrozole Micronised (Z), milled ...
Anastrozole at NUERNBERGER STRASSE ...
Issue/Submission Date
2007-03-09
2019-01-25
2010-10-13
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ATOVAQUONE
Issue/Submission Date
2008-03-28
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ATOVAQUONE
Issue/Submission Date
2008-03-28
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
AZATHIOPRINE
Issue/Submission Date
2009-11-30
CEP/COS

Application Number
Status
VALID
Filing Details
Azathioprine
Issue/Submission Date
2016-12-15
Japanese DMF

Application Number
Status
 
Filing Details
Azathioprine at NUERNBERGER STRASSE...
Issue/Submission Date
2013-11-20
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
AZATHIOPRINE
Azathioprine
Azathioprine at NUERNBERGER STRASSE...
Issue/Submission Date
2009-11-30
2016-12-15
2013-11-20
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
BACLOFEN
Issue/Submission Date
1988-02-02
CEP/COS

Application Number
Status
VALID
Filing Details
Baclofen
Issue/Submission Date
2016-12-15
Japanese DMF

Application Number
Status
 
Filing Details
Baclofen at NUERNBERGER STRASSE 12,...
Issue/Submission Date
2008-12-12
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Filing Details
BACLOFEN
Baclofen
Baclofen at NUERNBERGER STRASSE 12,...
Issue/Submission Date
1988-02-02
2016-12-15
2008-12-12
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
R-BACLOFEN
Issue/Submission Date
2007-09-25
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
R-BACLOFEN
Issue/Submission Date
2007-09-25
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Benzbromarone at NUERNBERGER STRASS...
Issue/Submission Date
2008-02-05
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Benzbromarone at NUERNBERGER STRASS...
Issue/Submission Date
2008-02-05
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
BICALUTAMIDE
Issue/Submission Date
2005-09-19
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Bicalutamide
Issue/Submission Date
2018-08-03
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Bicalutamide at NUERNBERGER STRASSE...
Issue/Submission Date
2008-12-12
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
BICALUTAMIDE
Bicalutamide
Bicalutamide at NUERNBERGER STRASSE...
Issue/Submission Date
2005-09-19
2018-08-03
2008-12-12
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
BICALUTAMIDE MILLED Z
Issue/Submission Date
2008-08-04
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
BICALUTAMIDE MILLED Z
Issue/Submission Date
2008-08-04
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
BISOPROLOL HEMIFUMARATE
Issue/Submission Date
1997-10-23
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
BISOPROLOL HEMIFUMARATE
Issue/Submission Date
1997-10-23
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
BUPIVACAINE (S) HYDROCHLORIDE
Issue/Submission Date
2011-07-27
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
BUPIVACAINE (S) HYDROCHLORIDE
Issue/Submission Date
2011-07-27
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
Bupivacaine Hydrochloride
Issue/Submission Date
2007-12-20
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Bupivacaine hydrochloride
Issue/Submission Date
2016-12-09
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Filing Details
Bupivacaine Hydrochloride
Bupivacaine hydrochloride
Issue/Submission Date
2007-12-20
2016-12-09
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
BUSPIRONE HYDROCHLORIDE
Issue/Submission Date
1991-06-11
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
BUSPIRONE HYDROCHLORIDE
Issue/Submission Date
1991-06-11
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
BUSULFAN
Issue/Submission Date
2013-06-06
CEP/COS

Application Number
Status
VALID
Filing Details
Busulfan
Issue/Submission Date
2016-12-09
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Filing Details
BUSULFAN
Busulfan
Issue/Submission Date
2013-06-06
2016-12-09
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Capecitabine
Issue/Submission Date
2016-12-15
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
VALID
 
Filing Details
Capecitabine
Issue/Submission Date
2016-12-15
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CEVIMELINE HYDROCHLORIDE
Issue/Submission Date
2008-11-17
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
CEVIMELINE HYDROCHLORIDE
Issue/Submission Date
2008-11-17
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
DEFEROXAMINE MESYLATE
Issue/Submission Date
2005-06-27
CEP/COS

Application Number
Status
VALID
Filing Details
Deferoxamine mesilate Produced by a...
Issue/Submission Date
2018-06-12
Japanese DMF

Application Number
Status
 
Filing Details
Deferoxamine mesylate at NUERNBERGE...
Issue/Submission Date
2011-11-14
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
DEFEROXAMINE MESYLATE
Deferoxamine mesilate Produced by a...
Deferoxamine mesylate at NUERNBERGE...
Issue/Submission Date
2005-06-27
2018-06-12
2011-11-14
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DEFEROXAMINE MESYLATE USP
Issue/Submission Date
2012-03-01
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
DEFEROXAMINE MESYLATE USP
Issue/Submission Date
2012-03-01
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
DICLOFENAC SODIUM
Issue/Submission Date
2000-12-04
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
DICLOFENAC SODIUM
Issue/Submission Date
2000-12-04
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
CEP/COS

Application Number
Status
VALID
Filing Details
Dobutamine hydrochloride
Issue/Submission Date
2016-12-09
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
VALID
 
Filing Details
Dobutamine hydrochloride
Issue/Submission Date
2016-12-09
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DOXAZOSIN MESYLATE
Issue/Submission Date
1997-08-27
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Doxazosin mesilate
Issue/Submission Date
2016-12-09
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Doxazosin mesylate at NUERNBERGER S...
Issue/Submission Date
2006-04-27
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Filing Details
DOXAZOSIN MESYLATE
Doxazosin mesilate
Doxazosin mesylate at NUERNBERGER S...
Issue/Submission Date
1997-08-27
2016-12-09
2006-04-27
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
EXPIRED
Filing Details
Enalapril maleate
Issue/Submission Date
2008-06-13
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
EXPIRED
 
Filing Details
Enalapril maleate
Issue/Submission Date
2008-06-13
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ENALAPRILAT
Issue/Submission Date
1998-12-17
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ENALAPRILAT
Issue/Submission Date
1998-12-17
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
EPINASTINE HYDROCHLORIDE
Issue/Submission Date
2007-11-02
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
EPINASTINE HYDROCHLORIDE
Issue/Submission Date
2007-11-02
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Estramustine Phosphate Sodium at NU...
Issue/Submission Date
2009-12-15
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Estramustine Phosphate Sodium at NU...
Issue/Submission Date
2009-12-15
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
FLUNIXIN MEGLUMINE
Issue/Submission Date
1996-12-19
Supporting Info
CEP/COS

Application Number
Status
WITHDRAWN BY HOLDER
Filing Details
Flunixin meglumine for veterinary u...
Issue/Submission Date
2013-07-11
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
WITHDRAWN BY HOLDER
 
Filing Details
FLUNIXIN MEGLUMINE
Flunixin meglumine for veterinary u...
Issue/Submission Date
1996-12-19
2013-07-11
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
FLUTAMIDE
Issue/Submission Date
2000-02-09
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CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
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Japanese DMF

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Status
 
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Issue/Submission Date
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Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
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FLUTAMIDE
Issue/Submission Date
2000-02-09
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
GANCICLOVIR
Issue/Submission Date
2001-07-31
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CEP/COS

Application Number
Status
VALID
Filing Details
Ganciclovir
Issue/Submission Date
2017-12-12
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Japanese DMF

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Status
 
Filing Details
Ganciclovir at NUERNBERGER STRASSE ...
Issue/Submission Date
2010-12-24
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Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
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Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Filing Details
GANCICLOVIR
Ganciclovir
Ganciclovir at NUERNBERGER STRASSE ...
Issue/Submission Date
2001-07-31
2017-12-12
2010-12-24
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USDMF

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Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
GANCICLOVIR ANHYDROUS R
Issue/Submission Date
2010-11-05
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CEP/COS

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Status
Filing Details
Issue/Submission Date
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Japanese DMF

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Status
 
Filing Details
Issue/Submission Date
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Written Confirmation

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Status
Filing Details
Issue/Submission Date
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Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
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GANCICLOVIR ANHYDROUS R
Issue/Submission Date
2010-11-05
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
GANCICLOVIR SODIUM
Issue/Submission Date
2003-11-17
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CEP/COS

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Status
Filing Details
Issue/Submission Date
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Japanese DMF

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Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
GANCICLOVIR SODIUM
Issue/Submission Date
2003-11-17
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
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HALOPERIDOL
Issue/Submission Date
1999-06-22
CEP/COS

Application Number
Status
VALID
Filing Details
Haloperidol
Issue/Submission Date
2018-10-08
Japanese DMF

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Status
 
Filing Details
Haloperidol at NUERNBERGER STRASSE ...
Issue/Submission Date
2009-02-23
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Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
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HALOPERIDOL
Haloperidol
Haloperidol at NUERNBERGER STRASSE ...
Issue/Submission Date
1999-06-22
2018-10-08
2009-02-23
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
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HALOPERIDOL DECANOATE
Issue/Submission Date
2006-02-21
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CEP/COS

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Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

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Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
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HALOPERIDOL DECANOATE
Issue/Submission Date
2006-02-21
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USDMF

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Status
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Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
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Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

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Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
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LANTHANUM CARBONATE
Issue/Submission Date
2008-10-17
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CEP/COS

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Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

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Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

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Status
Filing Details
Issue/Submission Date
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Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
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LANTHANUM CARBONATE
Issue/Submission Date
2008-10-17
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USDMF

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Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
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Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

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Filing Details
Issue/Submission Date
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Status
 
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USDMF

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Status
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Facility Fees - Paid
DMF Review - Complete
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LEVOTHYROXINE SODIUM
Issue/Submission Date
2011-10-20
CEP/COS

Application Number
Status
VALID
Filing Details
Levothyroxine sodium
Issue/Submission Date
2019-03-21
Japanese DMF

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Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
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LEVOTHYROXINE SODIUM
Levothyroxine sodium
Issue/Submission Date
2011-10-20
2019-03-21
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
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MASITINIB MESYLATE
Issue/Submission Date
2011-03-30
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CEP/COS

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Status
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Issue/Submission Date
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Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

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Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
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MASITINIB MESYLATE
Issue/Submission Date
2011-03-30
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USDMF

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Status
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Facility Fees - Paid
DMF Review - N/A
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MASITINIB MESYLATE
Issue/Submission Date
2017-01-10
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CEP/COS

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Status
Filing Details
Issue/Submission Date
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Status
 
Filing Details
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Status
Filing Details
Issue/Submission Date
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Application Number
Status
Status - Active
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DMF Review - N/A
 
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MASITINIB MESYLATE
Issue/Submission Date
2017-01-10
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
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METHOTREXATE
Issue/Submission Date
1995-10-05
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Methotrexate
Issue/Submission Date
2018-08-30
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Japanese DMF

Application Number
Status
 
Filing Details
Methotrexate at NUERNBERGER STRASSE...
Issue/Submission Date
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Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Filing Details
METHOTREXATE
Methotrexate
Methotrexate at NUERNBERGER STRASSE...
Issue/Submission Date
1995-10-05
2018-08-30
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
METHOTREXATE SODIUM
Issue/Submission Date
1997-04-11
Supporting Info
CEP/COS

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Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

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Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

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Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
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METHOTREXATE SODIUM
Issue/Submission Date
1997-04-11
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USDMF

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Status
Filing Details
Issue/Submission Date
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

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Status
Filing Details
Issue/Submission Date
Application Number
Status
 
Filing Details
Issue/Submission Date
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USDMF

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Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Mianserin hydrochloride
Issue/Submission Date
2019-01-22
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Japanese DMF

Application Number
Status
 
Filing Details
Mianserin hydrochloride at NUERNBER...
Issue/Submission Date
2008-10-27
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Filing Details
Issue/Submission Date
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