Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070045
Company: MYLAN PHARMS INC
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
09/24/1985 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
05/09/2016 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

12/30/2015 SUPPL-26 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

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

Label is not available on this site.

02/05/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

05/05/1994 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

10/10/1991 SUPPL-20 Labeling

Label is not available on this site.

10/31/1991 SUPPL-19 Labeling

Label is not available on this site.

10/31/1991 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

06/04/1991 SUPPL-17 Labeling

Label is not available on this site.

01/31/1990 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

08/30/1989 SUPPL-15 Labeling

Label is not available on this site.

01/04/1989 SUPPL-13 Labeling

Label is not available on this site.

06/21/1988 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/04/1988 SUPPL-9 Labeling

Label is not available on this site.

05/13/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/24/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/24/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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