An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 212809
Company: AJANTA PHARMA LTD

Products on ANDA 212809

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212809

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/13/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212809

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	214442	CHANGZHOU PHARM
CAPTOPRIL	CAPTOPRIL	12.5MG	TABLET;ORAL	Prescription	No	AB	074737	COREPHARMA
CAPTOPRIL	CAPTOPRIL	12.5MG	TABLET;ORAL	Prescription	No	AB	074505	HIKMA INTL PHARMS
CAPTOPRIL	CAPTOPRIL	12.5MG	TABLET;ORAL	Prescription	No	AB	074677	INNOGENIX
CAPTOPRIL	CAPTOPRIL	12.5MG	TABLET;ORAL	Prescription	No	AB	074477	PRINSTON INC
CAPTOPRIL	CAPTOPRIL	12.5MG	TABLET;ORAL	Prescription	No	AB	074532	WOCKHARDT

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	214442	CHANGZHOU PHARM
CAPTOPRIL	CAPTOPRIL	25MG	TABLET;ORAL	Prescription	No	AB	074737	COREPHARMA
CAPTOPRIL	CAPTOPRIL	25MG	TABLET;ORAL	Prescription	No	AB	074505	HIKMA INTL PHARMS
CAPTOPRIL	CAPTOPRIL	25MG	TABLET;ORAL	Prescription	No	AB	074677	INNOGENIX
CAPTOPRIL	CAPTOPRIL	25MG	TABLET;ORAL	Prescription	No	AB	074477	PRINSTON INC
CAPTOPRIL	CAPTOPRIL	25MG	TABLET;ORAL	Prescription	No	AB	074532	WOCKHARDT

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	214442	CHANGZHOU PHARM
CAPTOPRIL	CAPTOPRIL	50MG	TABLET;ORAL	Prescription	No	AB	074737	COREPHARMA
CAPTOPRIL	CAPTOPRIL	50MG	TABLET;ORAL	Prescription	No	AB	074505	HIKMA INTL PHARMS
CAPTOPRIL	CAPTOPRIL	50MG	TABLET;ORAL	Prescription	No	AB	074677	INNOGENIX
CAPTOPRIL	CAPTOPRIL	50MG	TABLET;ORAL	Prescription	No	AB	074477	PRINSTON INC
CAPTOPRIL	CAPTOPRIL	50MG	TABLET;ORAL	Prescription	No	AB	074532	WOCKHARDT

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	214442	CHANGZHOU PHARM
CAPTOPRIL	CAPTOPRIL	100MG	TABLET;ORAL	Prescription	No	AB	074737	COREPHARMA
CAPTOPRIL	CAPTOPRIL	100MG	TABLET;ORAL	Prescription	No	AB	074505	HIKMA INTL PHARMS
CAPTOPRIL	CAPTOPRIL	100MG	TABLET;ORAL	Prescription	No	AB	074677	INNOGENIX
CAPTOPRIL	CAPTOPRIL	100MG	TABLET;ORAL	Prescription	No	AB	074477	PRINSTON INC
CAPTOPRIL	CAPTOPRIL	100MG	TABLET;ORAL	Prescription	No	AB	074532	WOCKHARDT

Top