Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212743
Company: PAR PHARM INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLORZOXAZONE CHLORZOXAZONE 750MG TABLET;ORAL Prescription AB No No
CHLORZOXAZONE CHLORZOXAZONE 375MG TABLET;ORAL Prescription AB 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
11/02/2020 ORIG-1 Approval STANDARD

Label is not available on this site.

CHLORZOXAZONE

TABLET;ORAL; 750MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHLORZOXAZONE CHLORZOXAZONE 750MG TABLET;ORAL Prescription No AB 212185 GLENMARK PHARMS LTD
CHLORZOXAZONE CHLORZOXAZONE 750MG TABLET;ORAL Prescription No AB 212053 I3 PHARMS
CHLORZOXAZONE CHLORZOXAZONE 750MG TABLET;ORAL Prescription No AB 211849 MAYNE PHARMA
CHLORZOXAZONE CHLORZOXAZONE 750MG TABLET;ORAL Prescription No AB 040861 MIKART
CHLORZOXAZONE CHLORZOXAZONE 750MG TABLET;ORAL Prescription No AB 212253 NOVITIUM PHARMA
CHLORZOXAZONE CHLORZOXAZONE 750MG TABLET;ORAL Prescription No AB 212743 PAR PHARM INC
CHLORZOXAZONE CHLORZOXAZONE 750MG TABLET;ORAL Prescription No AB 212898 TEVA PHARMS USA INC

TABLET;ORAL; 375MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHLORZOXAZONE CHLORZOXAZONE 375MG TABLET;ORAL Prescription No AB 212185 GLENMARK PHARMS LTD
CHLORZOXAZONE CHLORZOXAZONE 375MG TABLET;ORAL Prescription No AB 212053 I3 PHARMS
CHLORZOXAZONE CHLORZOXAZONE 375MG TABLET;ORAL Prescription No AB 211849 MAYNE PHARMA
CHLORZOXAZONE CHLORZOXAZONE 375MG TABLET;ORAL Prescription No AB 040861 MIKART
CHLORZOXAZONE CHLORZOXAZONE 375MG TABLET;ORAL Prescription No AB 212253 NOVITIUM PHARMA
CHLORZOXAZONE CHLORZOXAZONE 375MG TABLET;ORAL Prescription No AB 212743 PAR PHARM INC
CHLORZOXAZONE CHLORZOXAZONE 375MG TABLET;ORAL Prescription No AB 212898 TEVA PHARMS USA INC

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