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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089853
Company: AUROBINDO PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLORZOXAZONE CHLORZOXAZONE 500MG TABLET;ORAL Prescription AA 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
05/04/1988 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
06/05/1996 SUPPL-4 Labeling

Label is not available on this site.

12/30/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/01/1989 SUPPL-2 Labeling

Label is not available on this site.

11/04/1988 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 214941 COREPHARMA
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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