Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 074434
Company: AUROBINDO PHARMA USA

Products on ANDA 074434

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CAPTOPRIL	CAPTOPRIL	12.5MG	TABLET;ORAL	Discontinued	None	No	No
CAPTOPRIL	CAPTOPRIL	25MG	TABLET;ORAL	Discontinued	None	No	No
CAPTOPRIL	CAPTOPRIL	50MG	TABLET;ORAL	Discontinued	None	No	No
CAPTOPRIL	CAPTOPRIL	100MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074434

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-16	Labeling-Package Insert		Label is not available on this site.
11/09/2015	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
04/22/2015	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
04/22/2015	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
07/19/2004	SUPPL-7	Labeling		Label is not available on this site.
04/22/2002	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
11/13/2001	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
12/13/1999	SUPPL-4	Labeling		Label is not available on this site.
02/27/1998	SUPPL-3	Labeling		Label is not available on this site.
10/14/1997	SUPPL-2	Labeling		Label is not available on this site.
10/30/1997	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.