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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074737
Company: COREPHARMA

Products on ANDA 074737

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 074737

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
07/08/2024	SUPPL-13	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 074737

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	074677	ANDAS 5 HOLDING
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	074477	PRINSTON INC
CAPTOPRIL	CAPTOPRIL	12.5MG	TABLET;ORAL	Prescription	No	AB	074532	WOCKHARDT BIO AG

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	074677	ANDAS 5 HOLDING
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	074477	PRINSTON INC
CAPTOPRIL	CAPTOPRIL	25MG	TABLET;ORAL	Prescription	No	AB	074532	WOCKHARDT BIO AG

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	074677	ANDAS 5 HOLDING
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	074477	PRINSTON INC
CAPTOPRIL	CAPTOPRIL	50MG	TABLET;ORAL	Prescription	No	AB	074532	WOCKHARDT BIO AG

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	074677	ANDAS 5 HOLDING
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	074477	PRINSTON INC
CAPTOPRIL	CAPTOPRIL	100MG	TABLET;ORAL	Prescription	No	AB	074532	WOCKHARDT BIO AG

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