Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 073093
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BACLOFEN BACLOFEN 20MG 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
01/28/1994 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
04/12/2001 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

03/21/2000 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

07/08/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/07/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/28/1997 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/31/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/31/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/24/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/17/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/13/1994 SUPPL-1 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