Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070908
Company: SUN PHARM INDUSTRIES

Products on ANDA 070908

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 070908

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/26/1986	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
12/01/1998	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
12/23/1994	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
10/11/1994	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
05/18/1993	SUPPL-23	Labeling		Label is not available on this site.
05/18/1993	SUPPL-22	Labeling		Label is not available on this site.
04/03/1992	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
03/12/1992	SUPPL-17	Labeling		Label is not available on this site.
01/26/1989	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
04/10/1995	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
02/22/1988	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
02/23/1988	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
03/31/1987	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/31/1987	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
11/05/1986	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
12/17/1986	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.