Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071547
Company: WATSON LABS

Products on ANDA 071547

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IBUPROFEN	IBUPROFEN	800MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071547

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/02/1987	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
05/06/2016	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/09/2016	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/09/1991	SUPPL-14	Labeling		Label is not available on this site.
08/09/1991	SUPPL-13	Labeling		Label is not available on this site.
11/19/1990	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
08/07/1991	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
07/10/1989	SUPPL-9	Labeling		Label is not available on this site.
09/23/1992	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
03/18/1992	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
03/24/1989	SUPPL-5	Labeling		Label is not available on this site.
03/18/1992	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/18/1992	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
07/08/1988	SUPPL-2	Labeling		Label is not available on this site.
04/04/1988	SUPPL-1	Labeling		Label is not available on this site.