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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Edmond Pharma Srl

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CARTEOLOL HYDROCHLORIDE

Clenbuterol Hydrochloride

DEXMEDETOMIDINE HCL

Gliclazide

Glimepiride

ISOPROTERENOL HYDROCHLORIDE

Indapamide

LURASIDONE HYDROCHLORIDE

MIDODRINE HYDROCHLORIDE

Prednicarbate

Procaterol hydrochloride hydrate

Ropivacaine hydrochloride monohydrate

Stanozolol Micronised

TRIMEBUTINE MALEATE

TULOBUTEROL BASE

Tenoxicam

Terfenadine

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Status - Active

Status - Inactive

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EXPIRED

VALID

WITHDRAWN BY HOLDER

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217MF10582

218MF10871

218MF10948

221MF10193

222MF10141

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USDMF

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

Application Number
Status
WITHDRAWN BY HOLDER
Filing Details
Carteolol hydrochloride
Issue/Submission Date
2015-04-24
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WITHDRAWN BY HOLDER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
CARTEOLOL HYDROCHLORIDE
Carteolol hydrochloride
Issue/Submission Date
1997-10-23
2015-04-24
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
Clenbuterol Hydrochloride
Issue/Submission Date
2015-04-24
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
Clenbuterol Hydrochloride
Issue/Submission Date
2015-04-24
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DEXMEDETOMIDINE HCL
Issue/Submission Date
2013-03-12
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
DEXMEDETOMIDINE HCL
Issue/Submission Date
2013-03-12
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
Gliclazide at Via G. B. Grassi 15-2...
Issue/Submission Date
2009-08-31
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Gliclazide at Via G. B. Grassi 15-2...
Issue/Submission Date
2009-08-31
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
Glimepiride
Issue/Submission Date
2015-04-24
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
Glimepiride
Issue/Submission Date
2015-04-24
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
Indapamide
Issue/Submission Date
2017-01-18
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
Indapamide
Issue/Submission Date
2017-01-18
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ISOPROTERENOL HYDROCHLORIDE
Issue/Submission Date
2017-05-15
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
ISOPROTERENOL HYDROCHLORIDE
Issue/Submission Date
2017-05-15
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
LURASIDONE HYDROCHLORIDE
Issue/Submission Date
2014-09-30
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
LURASIDONE HYDROCHLORIDE
Issue/Submission Date
2014-09-30
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
MIDODRINE HYDROCHLORIDE
Issue/Submission Date
2002-06-21
Supporting Info
CEP/COS

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

Application Number
Status
 
Filing Details
Midodrine hydrochloride at Strada S...
Issue/Submission Date
2005-09-14
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
MIDODRINE HYDROCHLORIDE
Midodrine hydrochloride at Strada S...
Issue/Submission Date
2002-06-21
2005-09-14
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
Prednicarbate
Issue/Submission Date
2017-11-21
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
Prednicarbate
Issue/Submission Date
2017-11-21
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
Procaterol hydrochloride hydrate at...
Issue/Submission Date
2006-11-24
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Procaterol hydrochloride hydrate at...
Issue/Submission Date
2006-11-24
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
Ropivacaine hydrochloride monohydra...
Issue/Submission Date
2017-05-22
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
Ropivacaine hydrochloride monohydra...
Issue/Submission Date
2017-05-22
Supporting Info
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USDMF

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

Application Number
Status
WITHDRAWN BY HOLDER
Filing Details
Stanozolol Micronised
Issue/Submission Date
2011-05-19
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
WITHDRAWN BY HOLDER
 
Filing Details
Stanozolol Micronised
Issue/Submission Date
2011-05-19
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
Tenoxicam
Issue/Submission Date
2015-04-24
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
Tenoxicam
Issue/Submission Date
2015-04-24
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
Terfenadine
Issue/Submission Date
2004-10-28
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
Terfenadine
Issue/Submission Date
2004-10-28
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
TRIMEBUTINE MALEATE at Via G. B. Gr...
Issue/Submission Date
2010-04-20
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
TRIMEBUTINE MALEATE at Via G. B. Gr...
Issue/Submission Date
2010-04-20
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
TULOBUTEROL BASE
Issue/Submission Date
2008-06-27
Supporting Info
CEP/COS

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

Application Number
Status
 
Filing Details
Tulobuterol at Strada Statale dei G...
Issue/Submission Date
2006-11-06
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
TULOBUTEROL BASE
Tulobuterol at Strada Statale dei G...
Issue/Submission Date
2008-06-27
2006-11-06
Supporting Info

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