Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071575
Company: STRIDES PHARMA

Products on ANDA 071575

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 071575

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/08/1987	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
06/08/2001	SUPPL-26	Labeling		Label is not available on this site.
06/08/2001	SUPPL-25	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/05/1998	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
01/14/1997	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
07/12/1996	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
07/15/1994	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
05/13/1996	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
10/26/1988	SUPPL-16	Bioequivalence		Label is not available on this site.
03/03/1989	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
03/03/1989	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
03/03/1989	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
12/15/1987	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
12/15/1987	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
09/09/1987	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
09/09/1987	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.