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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074024
Company: RISING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KETOPROFEN KETOPROFEN 50MG CAPSULE;ORAL Discontinued None No No
KETOPROFEN KETOPROFEN 75MG CAPSULE;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
12/29/1995 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-4 Labeling-Package Insert

Label is not available on this site.

04/22/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/20/1998 SUPPL-2 Labeling

Label is not available on this site.

10/21/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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