Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070437
Company: WATSON LABS
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
08/21/1985 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-24 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/09/2016 SUPPL-23 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/09/1991 SUPPL-19 Labeling

Label is not available on this site.

05/22/1991 SUPPL-18 Labeling

Label is not available on this site.

11/19/1990 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

08/07/1991 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/12/1989 SUPPL-14 Labeling

Label is not available on this site.

06/29/1990 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/24/1989 SUPPL-12 Labeling

Label is not available on this site.

01/30/1992 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/30/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/08/1988 SUPPL-8 Labeling

Label is not available on this site.

04/04/1988 SUPPL-7 Labeling

Label is not available on this site.

01/30/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/28/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

03/29/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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