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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Apothecon Pharmaceuticals

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01 Bendamustine Hydrochloride (1)

02 Benztropine (1)

03 Carmustine (1)

04 Cyclophosphamide (2)

05 Fomepizole (1)

06 Fosaprepitant (1)

07 Hydralazine Hydrochloride (2)

08 Iron Sucrose (2)

09 Maraviroc (1)

10 Melphalan Hydrochloride (1)

11 Miglustat (1)

12 Nicardipine Hydrochloride (1)

13 Penicillamine (1)

14 Phenoxybenzamine HCl (1)

15 Remifentanil (1)

16 Ropivacaine Hydrochloride (2)

17 Sevelamer Carbonate (1)

18 Sevelamer Hydrochloride (1)

19 Sodium Nitroprusside (1)

20 Sodium Phenylbutyrate (1)

21 Sodium ferric gluconate (1)

22 Taurolidine (1)

23 Trientine Hydrochloride (1)

24 Vitamin K1 (1)

25 Blank (1)

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01 Active (29)

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01 Blank (29)

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01 Blank (29)

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01 WC-0369 (8)

02 Blank (21)

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USDMF

Found USDMF

27272
Active
BENDAMUSTINE HYDROCHLORIDE MONOHYDR...
2013-09-19
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0369
Valid
Bendamustine Hydrochloride Monohydr...
2022-09-30
Application Number
27272
Indian CDSCO WC-0369
Status
Active
Fees Paid
Reviewed
 
Valid
2025-09-08
Filing Details
BENDAMUSTINE HYDROCHLORIDE MONOHYDR...
Bendamustine Hydrochloride Monohydr...
Issue/Submission Date
2013-09-19
2022-09-30
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USDMF

Found USDMF

30492
Active
DS121 DRUG SUBTANCE
2016-09-06
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0369
Valid
Carmustine IH
2022-09-30
Application Number
30492
Indian CDSCO WC-0369
Status
Active
Fees Paid
Reviewed
 
Valid
2025-09-08
Filing Details
DS121 DRUG SUBTANCE
Carmustine IH
Issue/Submission Date
2016-09-06
2022-09-30
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USDMF

Found USDMF

35975
Active
CYCLOPHOSPHAMIDE USP (STERILE)
2021-09-28
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0369
Valid
Cyclophosphamide USP
2022-09-30
Application Number
35975
Indian CDSCO WC-0369
Status
Active
Fees Paid
Reviewed
 
Valid
2025-09-08
Filing Details
CYCLOPHOSPHAMIDE USP (STERILE)
Cyclophosphamide USP
Issue/Submission Date
2021-09-28
2022-09-30
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USDMF

Found USDMF

29766
Active
MELPHALAN HYDROCHLORIDE
2015-09-29
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0369
Valid
Melphalan Hydrochloride IH
2022-09-30
Application Number
29766
Indian CDSCO WC-0369
Status
Active
Fees Paid
Reviewed
 
Valid
2025-09-08
Filing Details
MELPHALAN HYDROCHLORIDE
Melphalan Hydrochloride IH
Issue/Submission Date
2015-09-29
2022-09-30
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USDMF

Found USDMF

19084
Active
ROPIVACAINE
2005-12-30
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0369
Valid
Ropivacaine Hydrochloride IH/Ropiva...
2022-09-30
Application Number
19084
Indian CDSCO WC-0369
Status
Active
Fees Paid
N/A
 
Valid
2025-09-08
Filing Details
ROPIVACAINE
Ropivacaine Hydrochloride IH/Ropiva...
Issue/Submission Date
2005-12-30
2022-09-30
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USDMF

Found USDMF

27405
Active
SEVELAMER CARBONATE
2014-01-02
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0369
Valid
Sevelamer Carbonate IH
2022-09-30
Application Number
27405
Indian CDSCO WC-0369
Status
Active
Fees Paid
Reviewed
 
Valid
2025-09-08
Filing Details
SEVELAMER CARBONATE
Sevelamer Carbonate IH
Issue/Submission Date
2014-01-02
2022-09-30
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USDMF

Found USDMF

30905
Active
TRIENTINE HYDROCHLORIDE USP
2016-09-15
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0369
Valid
Trientine Hydrochloride USP
2022-09-30
Application Number
30905
Indian CDSCO WC-0369
Status
Active
Fees Paid
Reviewed
 
Valid
2025-09-08
Filing Details
TRIENTINE HYDROCHLORIDE USP
Trientine Hydrochloride USP
Issue/Submission Date
2016-09-15
2022-09-30
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USDMF

Found USDMF

30910
Active
PHYTONADIONE USP (PROCESS A)
2016-09-20
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0369
Valid
Vitamin K1 (Phytonadione) USP
2022-09-30
Application Number
30910
Indian CDSCO WC-0369
Status
Active
Fees Paid
Reviewed
 
Valid
2025-09-08
Filing Details
PHYTONADIONE USP (PROCESS A)
Vitamin K1 (Phytonadione) USP
Issue/Submission Date
2016-09-20
2022-09-30
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USDMF

Found USDMF

32136
Active
BENZTROPINE MESYLATE USP
2018-02-09
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
32136
Status
Active
Fees Paid
Reviewed
 
Filing Details
BENZTROPINE MESYLATE USP
Issue/Submission Date
2018-02-09
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USDMF

Found USDMF

38232
Active
CYCLOPHOSPHAMIDE USP
2023-03-31
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
38232
Status
Active
Fees Paid
N/A
 
Filing Details
CYCLOPHOSPHAMIDE USP
Issue/Submission Date
2023-03-31
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