Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070435
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBUPROFEN IBUPROFEN 200MG 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
03/05/1986 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
06/08/1989 SUPPL-35 Bioequivalence

Label is not available on this site.

11/19/1990 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/30/1992 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/30/1992 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/23/1992 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/20/1986 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/20/1986 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/20/1986 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/20/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/25/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/25/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/30/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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