Athena Athena

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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Apotex Inc

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Apotex Inc
Canada Flag
Country
Country
Canada
Address
Address
150 Signet Drive, Toronto, Ontario, M9L 1T9
Telephone
Telephone
+1-800-268-4623
Linkedin
Linkedin
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Twitter

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ListList of Products
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USDMF

Found USDMF

21393
Active
PERINDOPRIL TERT-BUTYLAMINE
2008-03-05
CEP/COS

Found CEP/COS

R0-CEP 2019-196 - Rev 01
Valid
Perindopril tert-butylamine, PER55L...
2023-08-21
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0128
Expired
Perindopril tert-butylamine EP
2014-03-06
Application Number
21393
Indian CDSCO WC-0128
Status
Active
Fees Paid
N/A
Valid
 
Expired
2016-07-02
Filing Details
PERINDOPRIL TERT-BUTYLAMINE
Perindopril tert-butylamine, PER55L...
Perindopril tert-butylamine EP
Issue/Submission Date
2008-03-05
2023-08-21
2014-03-06
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USDMF

Found USDMF

15841
Active
ALLOPURINOL USP
2002-02-04
CEP/COS

Found CEP/COS

R1-CEP 2001-335 - Rev 03
Valid
Allopurinol
2021-03-05
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
15841
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
ALLOPURINOL USP
Allopurinol
Issue/Submission Date
2002-02-04
2021-03-05
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USDMF

Caution USDMF

22620
Inactive
CABERGOLINE USP
2009-03-13
CEP/COS

Found CEP/COS

CEP 2013-047 - Rev 02
Valid
Cabergoline
2023-11-08
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0128
Expired
Cabergoline (USP/EP)
2014-03-06
Application Number
22620
Indian CDSCO WC-0128
Status
Inactive
Fees Paid
N/A
Valid
 
Expired
2016-07-02
Filing Details
CABERGOLINE USP
Cabergoline
Cabergoline (USP/EP)
Issue/Submission Date
2009-03-13
2023-11-08
2014-03-06
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USDMF

Caution USDMF

21227
Inactive
MYCOPHENOLATE MOFETIL USP
2008-01-11
CEP/COS

Found CEP/COS

R1-CEP 2010-302 - Rev 01
Valid
Mycophenolate mofetil
2018-11-20
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0128
Expired
Mycophenolate Mofetil (USP/EP) 
2014-03-06
Application Number
21227
Indian CDSCO WC-0128
Status
Inactive
Fees Paid
N/A
Valid
 
Expired
2016-07-02
Filing Details
MYCOPHENOLATE MOFETIL USP
Mycophenolate mofetil
Mycophenolate Mofetil (USP/EP) 
Issue/Submission Date
2008-01-11
2018-11-20
2014-03-06
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USDMF

Found USDMF

15168
Active
PIRFENIDONE EP
2000-11-30
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

220MF10130
Pirfenidone at Av. Industria Automo...
2008-05-20
Written Confirmation

Close WC

Application Number
15168
220MF10130
Status
Active
Fees Paid
Reviewed
 
Filing Details
PIRFENIDONE EP
Pirfenidone at Av. Industria Automo...
Issue/Submission Date
2000-11-30
2008-05-20
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USDMF

Caution USDMF

21095
Inactive
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYD...
2007-11-30
CEP/COS

Found CEP/COS

R1-CEP 2011-112 - Rev 00
Valid
Pramipexole dihydrochloride monohyd...
2018-02-07
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0128
Expired
Pramipexole Dihydrochloride Monohyd...
2014-03-06
Application Number
21095
Indian CDSCO WC-0128
Status
Inactive
Fees Paid
N/A
Valid
 
Expired
2016-07-02
Filing Details
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYD...
Pramipexole dihydrochloride monohyd...
Pramipexole Dihydrochloride Monohyd...
Issue/Submission Date
2007-11-30
2018-02-07
2014-03-06
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USDMF

Found USDMF

17023
Active
PRAVASTATIN SODIUM
2003-12-11
CEP/COS

Found CEP/COS

R1-CEP 2003-101 - Rev 04
Valid
Pravastatin sodium
2019-11-05
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
17023
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
PRAVASTATIN SODIUM
Pravastatin sodium
Issue/Submission Date
2003-12-11
2019-11-05
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USDMF

Caution USDMF

24589
Inactive
RALOXIFENE HYDROCHLORIDE USP
2011-02-01
CEP/COS

Found CEP/COS

R0-CEP 2017-097 - Rev 00
Valid
Raloxifene hydrochloride
2019-02-06
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0128
Expired
Raloxifene Hydrochloride (USP/EP) 
2014-03-06
Application Number
24589
Indian CDSCO WC-0128
Status
Inactive
Fees Paid
N/A
Valid
 
Expired
2016-07-02
Filing Details
RALOXIFENE HYDROCHLORIDE USP
Raloxifene hydrochloride
Raloxifene Hydrochloride (USP/EP) 
Issue/Submission Date
2011-02-01
2019-02-06
2014-03-06
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USDMF

Caution USDMF

24061
Inactive
RIZATRIPTAN BENZOATE USP
2010-08-12
CEP/COS

Found CEP/COS

R1-CEP 2013-206 - Rev 00
Valid
Rizatriptan benzoate
2020-11-30
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0128
Expired
Rizartriptan Benzoate (USPIEP) 
2014-03-06
Application Number
24061
Indian CDSCO WC-0128
Status
Inactive
Fees Paid
N/A
Valid
 
Expired
2016-07-02
Filing Details
RIZATRIPTAN BENZOATE USP
Rizatriptan benzoate
Rizartriptan Benzoate (USPIEP) 
Issue/Submission Date
2010-08-12
2020-11-30
2014-03-06
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USDMF

Found USDMF

23326
Active
ANASTROZOLE USP
2009-12-01
CEP/COS

Caution CEP/COS

R0-CEP 2014-296 - Rev 00
Expired
Anastrozole
2016-01-15
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
23326
Status
Active
Fees Paid
N/A
Expired
 
Filing Details
ANASTROZOLE USP
Anastrozole
Issue/Submission Date
2009-12-01
2016-01-15
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USDMF

Found USDMF

28029
Active
DABIGATRAN ETEXILATE MESYLATE
2014-03-28
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0128
Expired
Dabigatran Etexilate Mesylate
2014-03-06
Application Number
28029
Indian CDSCO WC-0128
Status
Active
Fees Paid
Reviewed
 
Expired
2016-07-02
Filing Details
DABIGATRAN ETEXILATE MESYLATE
Dabigatran Etexilate Mesylate
Issue/Submission Date
2014-03-28
2014-03-06
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USDMF

Found USDMF

20685
Active
GATIFLOXACIN HEMIHYDRATE
2007-07-13
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0128
Expired
Gatifloxacin Hemihydrate USP
2014-03-06
Application Number
20685
Indian CDSCO WC-0128
Status
Active
Fees Paid
N/A
 
Expired
2016-07-02
Filing Details
GATIFLOXACIN HEMIHYDRATE
Gatifloxacin Hemihydrate USP
Issue/Submission Date
2007-07-13
2014-03-06
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USDMF

Caution USDMF

25746
Inactive
MYCOPHENOLATE MOFETIL USP
2012-01-31
CEP/COS

Found CEP/COS

R1-CEP 2013-263 - Rev 00
Valid
Mycophenolate mofetil, MYM
2019-02-07
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
25746
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
MYCOPHENOLATE MOFETIL USP
Mycophenolate mofetil, MYM
Issue/Submission Date
2012-01-31
2019-02-07
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USDMF

Found USDMF

30810
Active
PERINDOPRIL ARGININE
2016-08-30
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0128
Expired
Perindopril Arginine 
2014-03-06
Application Number
30810
Indian CDSCO WC-0128
Status
Active
Fees Paid
Reviewed
 
Expired
2016-07-02
Filing Details
PERINDOPRIL ARGININE
Perindopril Arginine 
Issue/Submission Date
2016-08-30
2014-03-06
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USDMF

Found USDMF

22949
Active
ACYCLOVIR USP
2009-07-16
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
22949
Status
Active
Fees Paid
Reviewed
 
Filing Details
ACYCLOVIR USP
Issue/Submission Date
2009-07-16
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USDMF

Found USDMF

15409
Active
ALENDRONATE SODIUM TRIHYDRATE USP
2001-04-30
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
15409
Status
Active
Fees Paid
N/A
 
Filing Details
ALENDRONATE SODIUM TRIHYDRATE USP
Issue/Submission Date
2001-04-30
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USDMF

Found USDMF

20595
Active
ALFUZOSIN HYDROCHLORIDE USP
2007-06-08
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
20595
Status
Active
Fees Paid
N/A
 
Filing Details
ALFUZOSIN HYDROCHLORIDE USP
Issue/Submission Date
2007-06-08
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USDMF

Found USDMF

19957
Active
ARIPIPRAZOLE USP
2006-11-13
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
19957
Status
Active
Fees Paid
N/A
 
Filing Details
ARIPIPRAZOLE USP
Issue/Submission Date
2006-11-13
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USDMF

Found USDMF

20070
Active
ATOMOXETINE HYDROCHLORIDE USP
2007-05-18
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
20070
Status
Active
Fees Paid
N/A
 
Filing Details
ATOMOXETINE HYDROCHLORIDE USP
Issue/Submission Date
2007-05-18
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USDMF

Found USDMF

21574
Active
ATORVASTATIN CALCIUM PROPYLENE GLYC...
2008-04-29
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
21574
Status
Active
Fees Paid
Reviewed
 
Filing Details
ATORVASTATIN CALCIUM PROPYLENE GLYC...
Issue/Submission Date
2008-04-29
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USDMF

Found USDMF

18894
Active
BALSALAZIDE DISODIUM DIHYDRATE USP
2005-10-21
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
18894
Status
Active
Fees Paid
Reviewed
 
Filing Details
BALSALAZIDE DISODIUM DIHYDRATE USP
Issue/Submission Date
2005-10-21
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USDMF

Found USDMF

22509
Active
CEVIMELINE HYDROCHLORIDE HEMIHYDRAT...
2009-02-06
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
22509
Status
Active
Fees Paid
N/A
 
Filing Details
CEVIMELINE HYDROCHLORIDE HEMIHYDRAT...
Issue/Submission Date
2009-02-06
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USDMF

Found USDMF

22167
Active
CLONAZEPAM USP
2008-11-11
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
22167
Status
Active
Fees Paid
N/A
 
Filing Details
CLONAZEPAM USP
Issue/Submission Date
2008-11-11
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USDMF

Found USDMF

15721
Active
CLOPIDOGREL BISULPHATE USP
2001-11-13
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
15721
Status
Active
Fees Paid
N/A
 
Filing Details
CLOPIDOGREL BISULPHATE USP
Issue/Submission Date
2001-11-13
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USDMF

Found USDMF

13929
Active
CYCLOSPORINE USP (BULK)
1999-01-04
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
13929
Status
Active
Fees Paid
Reviewed
 
Filing Details
CYCLOSPORINE USP (BULK)
Issue/Submission Date
1999-01-04
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USDMF

Found USDMF

10867
Active
DEFERIPRONE
1994-04-12
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
10867
Status
Active
Fees Paid
N/A
 
Filing Details
DEFERIPRONE
Issue/Submission Date
1994-04-12
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USDMF

Found USDMF

13039
Active
DOXAZOSIN MESYLATE USP
1998-06-22
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
13039
Status
Active
Fees Paid
N/A
 
Filing Details
DOXAZOSIN MESYLATE USP
Issue/Submission Date
1998-06-22
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USDMF

Found USDMF

21833
Active
DULOXETINE HYDROCHLORIDE USP
2008-07-30
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
21833
Status
Active
Fees Paid
Reviewed
 
Filing Details
DULOXETINE HYDROCHLORIDE USP
Issue/Submission Date
2008-07-30
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USDMF

Found USDMF

22713
Active
FAMCICLOVIR USP
2009-04-09
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
22713
Status
Active
Fees Paid
N/A
 
Filing Details
FAMCICLOVIR USP
Issue/Submission Date
2009-04-09
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USDMF

Found USDMF

14529
Active
FLUVOXAMINE MALEATE USP
1999-11-12
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
14529
Status
Active
Fees Paid
Reviewed
 
Filing Details
FLUVOXAMINE MALEATE USP
Issue/Submission Date
1999-11-12
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USDMF

Found USDMF

20525
Active
IBANDRONATE SODIUM
2007-05-11
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
20525
Status
Active
Fees Paid
N/A
 
Filing Details
IBANDRONATE SODIUM
Issue/Submission Date
2007-05-11
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USDMF

Found USDMF

22931
Active
LAMIVUDINE METHANOL SOLVATE USP
2009-07-08
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
22931
Status
Active
Fees Paid
N/A
 
Filing Details
LAMIVUDINE METHANOL SOLVATE USP
Issue/Submission Date
2009-07-08
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USDMF

Found USDMF

19458
Active
LEVOFLOXACIN USP
2006-05-19
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
19458
Status
Active
Fees Paid
N/A
 
Filing Details
LEVOFLOXACIN USP
Issue/Submission Date
2006-05-19
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USDMF

Found USDMF

21199
Active
MEMANTINE HYDROCHLORIDE USP
2007-12-21
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
21199
Status
Active
Fees Paid
Reviewed
 
Filing Details
MEMANTINE HYDROCHLORIDE USP
Issue/Submission Date
2007-12-21
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USDMF

Found USDMF

11758
Active
METHACHOLINE CHLORIDE USP
1995-11-28
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
11758
Status
Active
Fees Paid
N/A
 
Filing Details
METHACHOLINE CHLORIDE USP
Issue/Submission Date
1995-11-28
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USDMF

Found USDMF

18470
Active
MIDODRINE HYDROCHLORIDE USP
2005-06-30
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
18470
Status
Active
Fees Paid
N/A
 
Filing Details
MIDODRINE HYDROCHLORIDE USP
Issue/Submission Date
2005-06-30
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USDMF

Found USDMF

19113
Active
MOEXIPRIL HYDROCHLORIDE USP
2006-01-18
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
19113
Status
Active
Fees Paid
N/A
 
Filing Details
MOEXIPRIL HYDROCHLORIDE USP
Issue/Submission Date
2006-01-18
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USDMF

Found USDMF

23495
Active
MONTELUKAST SODIUM USP
2010-01-29
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
23495
Status
Active
Fees Paid
N/A
 
Filing Details
MONTELUKAST SODIUM USP
Issue/Submission Date
2010-01-29
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USDMF

Found USDMF

22819
Active
MYCOPHENOLATE SODIUM USP
2009-05-28
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
22819
Status
Active
Fees Paid
N/A
 
Filing Details
MYCOPHENOLATE SODIUM USP
Issue/Submission Date
2009-05-28
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USDMF

Found USDMF

21980
Active
OLANZAPINE USP
2008-09-17
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
21980
Status
Active
Fees Paid
Reviewed
 
Filing Details
OLANZAPINE USP
Issue/Submission Date
2008-09-17
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USDMF

Found USDMF

17988
Active
OXCARBAZEPINE USP
2005-01-12
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
17988
Status
Active
Fees Paid
Reviewed
 
Filing Details
OXCARBAZEPINE USP
Issue/Submission Date
2005-01-12
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USDMF

Found USDMF

21440
Active
PAROXETINE HYDROCHLORIDE ANHYDROUS ...
2008-03-18
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
21440
Status
Active
Fees Paid
N/A
 
Filing Details
PAROXETINE HYDROCHLORIDE ANHYDROUS ...
Issue/Submission Date
2008-03-18
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USDMF

Found USDMF

20713
Active
RAMIPRIL USP
2007-07-24
CEP/COS

Close CEP/COS

Japanese DMF

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Written Confirmation

Close WC

Application Number
20713
Status
Active
Fees Paid
N/A
 
Filing Details
RAMIPRIL USP
Issue/Submission Date
2007-07-24
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USDMF

Found USDMF

21819
Active
RISEDRONATE SODIUM HEMIPENTAHYDRATE...
2008-07-18
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
21819
Status
Active
Fees Paid
Reviewed
 
Filing Details
RISEDRONATE SODIUM HEMIPENTAHYDRATE...
Issue/Submission Date
2008-07-18
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USDMF

Found USDMF

22252
Active
RIVASTIGMINE TARTRATE
2008-12-04
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
22252
Status
Active
Fees Paid
N/A
 
Filing Details
RIVASTIGMINE TARTRATE
Issue/Submission Date
2008-12-04
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USDMF

Found USDMF

18268
Active
TERAZOSIN HYDROCHLORIDE DIHYDRATE U...
2005-04-11
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
18268
Status
Active
Fees Paid
Reviewed
 
Filing Details
TERAZOSIN HYDROCHLORIDE DIHYDRATE U...
Issue/Submission Date
2005-04-11
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USDMF

Found USDMF

21487
Active
VALACYCLOVIR HYDROCHLORIDE MONOHYDR...
2008-04-01
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
21487
Status
Active
Fees Paid
N/A
 
Filing Details
VALACYCLOVIR HYDROCHLORIDE MONOHYDR...
Issue/Submission Date
2008-04-01
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USDMF

Found USDMF

21377
Active
VENLAFAXINE HYDROCHLORIDE USP
2008-02-26
CEP/COS

Close CEP/COS

Japanese DMF

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Written Confirmation

Close WC

Application Number
21377
Status
Active
Fees Paid
N/A
 
Filing Details
VENLAFAXINE HYDROCHLORIDE USP
Issue/Submission Date
2008-02-26
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USDMF

Found USDMF

11387
Active
WARFARIN SODIUM CLATHRATE USP
1995-03-15
CEP/COS

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Japanese DMF

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Written Confirmation

Close WC

Application Number
11387
Status
Active
Fees Paid
N/A
 
Filing Details
WARFARIN SODIUM CLATHRATE USP
Issue/Submission Date
1995-03-15
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USDMF

Found USDMF

18050
Active
ZIPRASIDONE HYDROCHLORIDE
2005-02-03
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
18050
Status
Active
Fees Paid
N/A
 
Filing Details
ZIPRASIDONE HYDROCHLORIDE
Issue/Submission Date
2005-02-03
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