Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074505
Company: HIKMA INTL PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CAPTOPRIL CAPTOPRIL 12.5MG TABLET;ORAL Prescription AB No No
CAPTOPRIL CAPTOPRIL 25MG TABLET;ORAL Prescription AB No No
CAPTOPRIL CAPTOPRIL 50MG TABLET;ORAL Prescription AB No No
CAPTOPRIL CAPTOPRIL 100MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/13/1996 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/23/2016 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

02/23/2016 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

12/05/2014 SUPPL-27 Labeling-Container/Carton Labels

Label is not available on this site.

11/03/2014 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

11/03/2014 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

07/22/2011 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

08/10/2001 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

10/25/2000 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/12/2000 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/27/1999 SUPPL-8 Labeling

Label is not available on this site.

10/25/2000 SUPPL-7 Labeling

Label is not available on this site.

10/25/2000 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/01/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/21/1998 SUPPL-4 Labeling

Label is not available on this site.

01/31/1997 SUPPL-3 Labeling

Label is not available on this site.

01/31/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/31/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

CAPTOPRIL

TABLET;ORAL; 12.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CAPTOPRIL CAPTOPRIL 12.5MG TABLET;ORAL Prescription No AB 074677 BOSCOGEN
CAPTOPRIL CAPTOPRIL 12.5MG TABLET;ORAL Prescription No AB 074505 HIKMA INTL PHARMS
CAPTOPRIL CAPTOPRIL 12.5MG TABLET;ORAL Prescription No AB 074434 MYLAN
CAPTOPRIL CAPTOPRIL 12.5MG TABLET;ORAL Prescription No AB 074477 PRINSTON INC
CAPTOPRIL CAPTOPRIL 12.5MG TABLET;ORAL Prescription No AB 212223 SETON PHARMS
CAPTOPRIL CAPTOPRIL 12.5MG TABLET;ORAL Prescription No AB 074322 TEVA
CAPTOPRIL CAPTOPRIL 12.5MG TABLET;ORAL Prescription No AB 074386 WATSON LABS
CAPTOPRIL CAPTOPRIL 12.5MG TABLET;ORAL Prescription No AB 074532 WOCKHARDT LTD

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CAPTOPRIL CAPTOPRIL 25MG TABLET;ORAL Prescription No AB 074677 BOSCOGEN
CAPTOPRIL CAPTOPRIL 25MG TABLET;ORAL Prescription No AB 074505 HIKMA INTL PHARMS
CAPTOPRIL CAPTOPRIL 25MG TABLET;ORAL Prescription No AB 074434 MYLAN
CAPTOPRIL CAPTOPRIL 25MG TABLET;ORAL Prescription No AB 074477 PRINSTON INC
CAPTOPRIL CAPTOPRIL 25MG TABLET;ORAL Prescription No AB 212223 SETON PHARMS
CAPTOPRIL CAPTOPRIL 25MG TABLET;ORAL Prescription No AB 074322 TEVA
CAPTOPRIL CAPTOPRIL 25MG TABLET;ORAL Prescription No AB 074386 WATSON LABS
CAPTOPRIL CAPTOPRIL 25MG TABLET;ORAL Prescription No AB 074532 WOCKHARDT LTD

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CAPTOPRIL CAPTOPRIL 50MG TABLET;ORAL Prescription No AB 074677 BOSCOGEN
CAPTOPRIL CAPTOPRIL 50MG TABLET;ORAL Prescription No AB 074505 HIKMA INTL PHARMS
CAPTOPRIL CAPTOPRIL 50MG TABLET;ORAL Prescription No AB 074434 MYLAN
CAPTOPRIL CAPTOPRIL 50MG TABLET;ORAL Prescription No AB 074477 PRINSTON INC
CAPTOPRIL CAPTOPRIL 50MG TABLET;ORAL Prescription No AB 212223 SETON PHARMS
CAPTOPRIL CAPTOPRIL 50MG TABLET;ORAL Prescription No AB 074322 TEVA
CAPTOPRIL CAPTOPRIL 50MG TABLET;ORAL Prescription No AB 074386 WATSON LABS
CAPTOPRIL CAPTOPRIL 50MG TABLET;ORAL Prescription No AB 074532 WOCKHARDT LTD

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CAPTOPRIL CAPTOPRIL 100MG TABLET;ORAL Prescription No AB 074677 BOSCOGEN
CAPTOPRIL CAPTOPRIL 100MG TABLET;ORAL Prescription No AB 074505 HIKMA INTL PHARMS
CAPTOPRIL CAPTOPRIL 100MG TABLET;ORAL Prescription No AB 074434 MYLAN
CAPTOPRIL CAPTOPRIL 100MG TABLET;ORAL Prescription No AB 074477 PRINSTON INC
CAPTOPRIL CAPTOPRIL 100MG TABLET;ORAL Prescription No AB 212223 SETON PHARMS
CAPTOPRIL CAPTOPRIL 100MG TABLET;ORAL Prescription No AB 074322 TEVA
CAPTOPRIL CAPTOPRIL 100MG TABLET;ORAL Prescription No AB 074386 WATSON LABS
CAPTOPRIL CAPTOPRIL 100MG TABLET;ORAL Prescription No AB 074532 WOCKHARDT LTD

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