Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071146
Company: IVAX SUB TEVA PHARMS

Products on ANDA 071146

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IBUPROFEN	IBUPROFEN	600MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071146

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/23/1986	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
05/05/1997	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
12/16/1992	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
12/16/1992	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
06/12/1991	SUPPL-16	Labeling		Label is not available on this site.
12/07/1990	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
12/07/1990	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
02/01/1989	SUPPL-13	Labeling		Label is not available on this site.
02/01/1989	SUPPL-12	Labeling		Label is not available on this site.
12/07/1990	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
01/11/1989	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
06/30/1988	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
06/30/1988	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
06/30/1988	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
04/06/1988	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
04/06/1988	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
08/26/1987	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.