Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075270
Company: ACTAVIS LABS FL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KETOPROFEN KETOPROFEN 200MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
KETOPROFEN KETOPROFEN 100MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
KETOPROFEN KETOPROFEN 150MG 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
03/24/1999 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75270ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/28/2021 SUPPL-14 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/09/2016 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/21/2008 SUPPL-10 Labeling

Label is not available on this site.

09/22/2006 SUPPL-8 Labeling

Label is not available on this site.

07/03/2006 SUPPL-7 Labeling

Label is not available on this site.

12/24/2002 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

09/20/2002 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

02/04/2000 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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