An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 213126
Company: RISING

Products on ANDA 213126

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	500MG	TABLET;ORAL	Prescription	AA	No	No
CHLORZOXAZONE	CHLORZOXAZONE	750MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213126

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/05/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213126

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	040861	ANDA REPOSITORY
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	212253	NOVITIUM PHARMA
CHLORZOXAZONE	CHLORZOXAZONE	375MG	TABLET;ORAL	Prescription	No	AB	212743	PH HEALTH
CHLORZOXAZONE	CHLORZOXAZONE	375MG	TABLET;ORAL	Prescription	No	AB	213126	RISING
CHLORZOXAZONE	CHLORZOXAZONE	375MG	TABLET;ORAL	Prescription	No	AB	212047	SOMERSET THERAPS LLC

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	213126	RISING
CHLORZOXAZONE	CHLORZOXAZONE	500MG	TABLET;ORAL	Prescription	No	AA	210961	SENORES PHARMS
CHLORZOXAZONE	CHLORZOXAZONE	500MG	TABLET;ORAL	Prescription	No	AA	089859	WATSON 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	040861	ANDA REPOSITORY
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	212253	NOVITIUM PHARMA
CHLORZOXAZONE	CHLORZOXAZONE	750MG	TABLET;ORAL	Prescription	No	AB	212743	PH HEALTH
CHLORZOXAZONE	CHLORZOXAZONE	750MG	TABLET;ORAL	Prescription	No	AB	213126	RISING
CHLORZOXAZONE	CHLORZOXAZONE	750MG	TABLET;ORAL	Prescription	No	AB	212047	SOMERSET THERAPS LLC

Top