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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212047
Company: UPSHER SMITH LABS

Products on ANDA 212047

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
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 212047

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/27/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212047

CHLORZOXAZONE

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

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