Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074363
Company: CHARTWELL RX

Products on ANDA 074363

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 074363

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/09/1995	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
03/27/2009	SUPPL-14	Labeling		Label is not available on this site.
12/05/2008	SUPPL-13	Labeling		Label is not available on this site.
10/29/2008	SUPPL-12	Labeling		Label is not available on this site.
05/14/2004	SUPPL-9	Labeling		Label is not available on this site.
03/25/2002	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
05/02/2001	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
04/22/1999	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
02/12/1998	SUPPL-5	Labeling		Label is not available on this site.
11/05/1997	SUPPL-4	Labeling		Label is not available on this site.
08/11/1997	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
06/05/1997	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
10/21/1996	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.