Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089853
Company: AUROBINDO PHARMA LTD

Products on ANDA 089853

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHLORZOXAZONE	CHLORZOXAZONE	500MG	TABLET;ORAL	Prescription	AA	No	No
CHLORZOXAZONE	CHLORZOXAZONE	375MG	TABLET;ORAL	Prescription	AB	No	No
CHLORZOXAZONE	CHLORZOXAZONE	750MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 089853

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
08/17/2023	SUPPL-9	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 089853

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	DR REDDYS LABS SA
CHLORZOXAZONE	CHLORZOXAZONE	500MG	TABLET;ORAL	Prescription	No	AA	212254	NOVITIUM PHARMA
CHLORZOXAZONE	CHLORZOXAZONE	500MG	TABLET;ORAL	Prescription	No	AA	210961	SENORES PHARMS
CHLORZOXAZONE	CHLORZOXAZONE	500MG	TABLET;ORAL	Prescription	No	AA	089859	WATSON LABS

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	089853	AUROBINDO PHARMA LTD
CHLORZOXAZONE	CHLORZOXAZONE	375MG	TABLET;ORAL	Prescription	No	AB	214941	COREPHARMA
CHLORZOXAZONE	CHLORZOXAZONE	375MG	TABLET;ORAL	Prescription	No	AB	211849	DR REDDYS LABS SA
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	213126	RISING
CHLORZOXAZONE	CHLORZOXAZONE	375MG	TABLET;ORAL	Prescription	No	AB	212898	TEVA PHARMS USA INC
CHLORZOXAZONE	CHLORZOXAZONE	375MG	TABLET;ORAL	Prescription	No	AB	212047	UPSHER SMITH LABS

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	089853	AUROBINDO PHARMA LTD
CHLORZOXAZONE	CHLORZOXAZONE	750MG	TABLET;ORAL	Prescription	No	AB	214941	COREPHARMA
CHLORZOXAZONE	CHLORZOXAZONE	750MG	TABLET;ORAL	Prescription	No	AB	211849	DR REDDYS LABS SA
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	213126	RISING
CHLORZOXAZONE	CHLORZOXAZONE	750MG	TABLET;ORAL	Prescription	No	AB	212898	TEVA PHARMS USA INC
CHLORZOXAZONE	CHLORZOXAZONE	750MG	TABLET;ORAL	Prescription	No	AB	212047	UPSHER SMITH LABS