Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088928
Company: ACTAVIS ELIZABETH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLORZOXAZONE CHLORZOXAZONE 250MG 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
04/19/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/11/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/11/1995 SUPPL-5 Labeling

Label is not available on this site.

12/11/1995 SUPPL-4 Manufacturing (CMC)-New Strength

Label is not available on this site.

10/18/1993 SUPPL-3 Labeling

Label is not available on this site.

09/16/1991 SUPPL-2 Labeling

Label is not available on this site.

09/16/1991 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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