Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089859
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLORZOXAZONE CHLORZOXAZONE 500MG TABLET;ORAL Prescription AA No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/04/1988 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
08/30/2001 SUPPL-31 Manufacturing (CMC)-Facility

Label is not available on this site.

07/07/2000 SUPPL-30 Manufacturing (CMC)-Facility

Label is not available on this site.

11/19/1999 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

03/09/1998 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

10/17/1997 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

12/13/1996 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

01/07/1997 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

09/20/1995 SUPPL-24 Labeling

Label is not available on this site.

10/03/1995 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

10/03/1995 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

10/03/1995 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/02/1995 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/31/1993 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/01/1993 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/01/1993 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/25/1992 SUPPL-5 Labeling

Label is not available on this site.

12/30/1992 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/08/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/09/1991 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/09/1991 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

CHLORZOXAZONE

TABLET;ORAL; 500MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHLORZOXAZONE CHLORZOXAZONE 500MG TABLET;ORAL Prescription No AA 089853 AUROBINDO PHARMA LTD
CHLORZOXAZONE CHLORZOXAZONE 500MG TABLET;ORAL Prescription No AA 211849 MAYNE PHARMA
CHLORZOXAZONE CHLORZOXAZONE 500MG TABLET;ORAL Prescription No AA 212254 NOVITIUM PHARMA
CHLORZOXAZONE CHLORZOXAZONE 500MG TABLET;ORAL Prescription No AA 089859 WATSON LABS

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