Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070436
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBUPROFEN IBUPROFEN 400MG 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
08/21/1985 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
05/06/2016 SUPPL-25 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/09/2016 SUPPL-24 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/09/1991 SUPPL-20 Labeling

Label is not available on this site.

04/24/1991 SUPPL-19 Labeling

Label is not available on this site.

11/19/1990 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

08/07/1991 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/24/1989 SUPPL-13 Labeling

Label is not available on this site.

06/15/1989 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/15/1989 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/08/1988 SUPPL-9 Labeling

Label is not available on this site.

04/04/1988 SUPPL-8 Labeling

Label is not available on this site.

09/23/1992 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/28/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/30/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/25/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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