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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074505
Company: HIKMA INTL PHARMS

Products on ANDA 074505

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074505

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
03/03/2020	SUPPL-31	Labeling-Package Insert		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 074505

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

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