Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070986
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBUPROFEN IBUPROFEN 800MG TABLET;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/25/1986 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
07/22/2019 SUPPL-34 Labeling-Package Insert

Label is not available on this site.

05/09/2016 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

03/13/1998 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

01/14/1997 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

07/15/1994 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

04/08/1994 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

01/10/1992 SUPPL-25 Labeling

Label is not available on this site.

06/11/1991 SUPPL-24 Labeling

Label is not available on this site.

02/21/1989 SUPPL-22 Labeling

Label is not available on this site.

12/30/1988 SUPPL-21 Labeling

Label is not available on this site.

11/22/1988 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

03/02/1989 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/02/1989 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

07/01/1988 SUPPL-16 Labeling

Label is not available on this site.

02/10/1988 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/22/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/02/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/20/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/23/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/17/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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