Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020499
Company: BAYER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACTRON KETOPROFEN 12.5MG 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
10/06/1995 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020499_actron_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/17/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/03/1995 SUPPL-1 Labeling

Label is not available on this site.

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