Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071735
Company: CONTRACT PHARMACAL

Products on ANDA 071735

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IBUPROFEN	IBUPROFEN	200MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071735

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/10/1987	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
03/22/2006	SUPPL-19	Labeling		Label is not available on this site.
12/01/1999	SUPPL-17	Labeling		Label is not available on this site.
07/23/1996	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
03/15/1996	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
04/24/1996	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
04/24/1996	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
07/24/1996	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
09/30/1994	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
08/24/1993	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
01/23/1990	SUPPL-8	Bioequivalence		Label is not available on this site.
08/27/1991	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
08/27/1991	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
05/12/1988	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
05/12/1988	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
05/12/1988	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.