Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 085961
Company: CLONMEL HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHOCARBAMOL METHOCARBAMOL 500MG 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
12/19/1977 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
10/01/1998 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

06/23/1998 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

06/23/1998 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

12/02/1994 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

03/26/1991 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/20/1989 SUPPL-18 Bioequivalence

Label is not available on this site.

03/26/1991 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/26/1991 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/02/1985 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/27/1984 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/06/1983 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/05/1982 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/15/1982 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/15/1982 SUPPL-8 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