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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212253
Company: NOVITIUM PHARMA

Products on ANDA 212253

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 212253

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/27/2019	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212253Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 212253

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	212743	ENDO OPERATIONS
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	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	212743	ENDO OPERATIONS
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	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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