Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071999
Company: MYLAN
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
12/03/1987 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
05/09/2016 SUPPL-19 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/22/2016 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

02/25/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/05/1998 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/05/1994 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

10/10/1991 SUPPL-12 Labeling

Label is not available on this site.

10/31/1991 SUPPL-11 Labeling

Label is not available on this site.

10/31/1991 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/24/1991 SUPPL-9 Labeling

Label is not available on this site.

01/31/1990 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/21/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/21/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/21/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/04/1988 SUPPL-1 Labeling

Label is not available on this site.

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