Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074386
Company: WATSON LABS
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
05/23/1996 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
04/25/2001 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/20/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/20/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/20/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/13/1998 SUPPL-2 Labeling

Label is not available on this site.

10/21/1997 SUPPL-1 Labeling

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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