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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070481
Company: STRIDES PHARMA INTL
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
10/18/1985 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
08/22/2007 SUPPL-39 Labeling

Label is not available on this site.

06/08/2001 SUPPL-38 Labeling

Label is not available on this site.

06/08/2001 SUPPL-37 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/05/1998 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

01/14/1997 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

07/12/1996 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

07/15/1994 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

02/13/1995 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

01/11/1994 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

01/11/1994 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

01/11/1994 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

01/11/1994 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

11/29/1988 SUPPL-24 Bioequivalence

Label is not available on this site.

03/20/1989 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

03/20/1989 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

03/20/1989 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/20/1989 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

03/20/1989 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

10/25/1988 SUPPL-17 Labeling

Label is not available on this site.

12/14/1987 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

09/09/1987 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/18/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/11/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/29/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/25/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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