Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070330
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBUPROFEN IBUPROFEN 600MG 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
08/06/1985 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
07/22/2019 SUPPL-39 Labeling-Package Insert

Label is not available on this site.

05/09/2016 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

03/13/1998 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

01/14/1997 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

04/29/1994 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

03/07/1994 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

01/10/1992 SUPPL-30 Labeling

Label is not available on this site.

06/11/1991 SUPPL-29 Labeling

Label is not available on this site.

02/21/1989 SUPPL-27 Labeling

Label is not available on this site.

03/02/1989 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/02/1989 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

03/02/1989 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

12/31/1987 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/10/1988 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

09/22/1987 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

09/22/1987 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/02/1988 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/02/1988 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/22/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/11/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/16/1986 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/26/1985 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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