Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071214
Company: OHM LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBUPROHM 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
12/01/1986 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
08/22/2008 SUPPL-21 Labeling

Label is not available on this site.

10/13/2006 SUPPL-20 Labeling

Label is not available on this site.

04/04/2006 SUPPL-18 Labeling

Label is not available on this site.

09/17/1999 SUPPL-13 Labeling

Label is not available on this site.

09/17/1999 SUPPL-12 Labeling

Label is not available on this site.

08/05/1994 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/21/1992 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/21/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/13/1992 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/10/1989 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/03/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/28/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/28/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/09/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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