Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075679
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KETOPROFEN KETOPROFEN 200MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None No Yes
KETOPROFEN KETOPROFEN 150MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
KETOPROFEN KETOPROFEN 100MG CAPSULE, EXTENDED RELEASE;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
02/20/2002 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75679.ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/28/2021 SUPPL-12 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/09/2016 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

01/08/2008 SUPPL-4 Labeling

Label is not available on this site.

07/03/2006 SUPPL-2 Labeling

Label is not available on this site.

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