Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 071575
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBUPROFEN IBUPROFEN 200MG 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
05/08/1987 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
06/08/2001 SUPPL-26 Labeling

Label is not available on this site.

06/08/2001 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/05/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

01/14/1997 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/12/1996 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

07/15/1994 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/13/1996 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/26/1988 SUPPL-16 Bioequivalence

Label is not available on this site.

03/03/1989 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/03/1989 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/03/1989 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

12/15/1987 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/15/1987 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/09/1987 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/09/1987 SUPPL-5 Manufacturing (CMC)

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