Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087211
Company: IVAX SUB TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHOCARBAMOL AND ASPIRIN ASPIRIN; METHOCARBAMOL 325MG;400MG 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
12/22/1982 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
07/29/2002 SUPPL-30 Manufacturing (CMC)-Facility

Label is not available on this site.

03/12/2002 SUPPL-29 Manufacturing (CMC)-Facility

Label is not available on this site.

03/07/2001 SUPPL-27 Manufacturing (CMC)-Facility

Label is not available on this site.

03/07/2001 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

03/07/2001 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

03/07/2001 SUPPL-24 Manufacturing (CMC)-Facility

Label is not available on this site.

01/19/2001 SUPPL-23 Manufacturing (CMC)-Facility

Label is not available on this site.

01/28/2000 SUPPL-22 Manufacturing (CMC)-Facility

Label is not available on this site.

11/23/1999 SUPPL-21 Manufacturing (CMC)-Facility

Label is not available on this site.

08/20/1999 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

12/09/1998 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/30/1997 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/17/1992 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

12/17/1992 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

08/01/1988 SUPPL-13 Bioequivalence

Label is not available on this site.

09/14/1988 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/14/1988 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/14/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/20/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/20/1987 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/16/1984 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/16/1984 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/13/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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