Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 072407
Company: WATSON LABS TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FENOPROFEN CALCIUM FENOPROFEN CALCIUM EQ 600MG BASE 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
06/13/1988 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
05/11/2016 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

05/09/2016 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

01/31/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/07/1991 SUPPL-8 Labeling

Label is not available on this site.

05/24/1989 SUPPL-6 Bioequivalence

Label is not available on this site.

04/21/1989 SUPPL-5 Labeling

Label is not available on this site.

07/11/1989 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/12/1989 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/11/1989 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/31/1989 SUPPL-1 Labeling

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English