Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072169
Company: SANDOZ
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
12/11/1987 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-11 Labeling-Package Insert

Label is not available on this site.

05/09/2016 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

01/28/2000 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/19/1989 SUPPL-6 Labeling

Label is not available on this site.

04/26/1989 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/25/1988 SUPPL-3 Labeling

Label is not available on this site.

06/30/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/07/1988 SUPPL-1 Labeling

Label is not available on this site.

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