Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070469
Company: OHM LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBUPROHM 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
08/29/1985 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
08/05/1994 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/21/1992 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/22/1991 SUPPL-11 Labeling

Label is not available on this site.

08/23/1989 SUPPL-10 Labeling

Label is not available on this site.

04/07/1989 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/07/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/22/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/15/1989 SUPPL-6 Labeling

Label is not available on this site.

02/12/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/12/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/21/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/27/1989 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/21/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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