Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070436
Company: WATSON LABS

Products on ANDA 070436

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IBUPROFEN	IBUPROFEN	400MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070436

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/21/1985	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
05/06/2016	SUPPL-25	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/09/2016	SUPPL-24	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/09/1991	SUPPL-20	Labeling		Label is not available on this site.
04/24/1991	SUPPL-19	Labeling		Label is not available on this site.
11/19/1990	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
08/07/1991	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
03/24/1989	SUPPL-13	Labeling		Label is not available on this site.
06/15/1989	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
04/15/1989	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
07/08/1988	SUPPL-9	Labeling		Label is not available on this site.
04/04/1988	SUPPL-8	Labeling		Label is not available on this site.
09/23/1992	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
10/28/1986	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
04/30/1986	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
03/25/1986	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.