Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070083
Company: BASF

Products on ANDA 070083

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070083

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/22/1985	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
02/15/1995	SUPPL-20	Labeling		Label is not available on this site.
08/11/1995	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
09/30/1994	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
09/30/1994	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
05/03/1993	SUPPL-16	Labeling		Label is not available on this site.
03/11/1992	SUPPL-15	Labeling		Label is not available on this site.
10/24/1991	SUPPL-14	Labeling		Label is not available on this site.
08/06/1991	SUPPL-13	Labeling		Label is not available on this site.
09/06/1989	SUPPL-12	Labeling		Label is not available on this site.
02/14/1989	SUPPL-10	Labeling		Label is not available on this site.
02/14/1989	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
03/01/1988	SUPPL-8	Labeling		Label is not available on this site.
05/23/1986	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
01/16/1986	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
01/16/1986	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
01/16/1986	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
01/16/1986	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.