Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074737
Company: ANNORA PHARMA
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
10/28/1998 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74737ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/03/2020 SUPPL-11 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

02/16/2016 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

02/16/2016 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

01/20/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

04/08/2011 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

11/13/2007 SUPPL-5 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 212809 AJANTA PHARMA LTD
CAPTOPRIL CAPTOPRIL 12.5MG TABLET;ORAL Prescription No AB 074737 ANNORA PHARMA
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 074477 PRINSTON INC
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 212809 AJANTA PHARMA LTD
CAPTOPRIL CAPTOPRIL 25MG TABLET;ORAL Prescription No AB 074737 ANNORA PHARMA
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 074477 PRINSTON INC
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 212809 AJANTA PHARMA LTD
CAPTOPRIL CAPTOPRIL 50MG TABLET;ORAL Prescription No AB 074737 ANNORA PHARMA
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 074477 PRINSTON INC
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 212809 AJANTA PHARMA LTD
CAPTOPRIL CAPTOPRIL 100MG TABLET;ORAL Prescription No AB 074737 ANNORA PHARMA
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 074477 PRINSTON INC
CAPTOPRIL CAPTOPRIL 100MG TABLET;ORAL Prescription No AB 074532 WOCKHARDT LTD

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