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): 207483
Company: ANDA REPOSITORY

Products on ANDA 207483

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHLORZOXAZONE	CHLORZOXAZONE	250MG	TABLET;ORAL	Prescription	AA	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207483

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/24/2016	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 207483

CHLORZOXAZONE

TABLET;ORAL; 250MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CHLORZOXAZONE	CHLORZOXAZONE	250MG	TABLET;ORAL	Prescription	No	AA	215540	AJENAT PHARMS
CHLORZOXAZONE	CHLORZOXAZONE	250MG	TABLET;ORAL	Prescription	No	AA	207483	ANDA REPOSITORY
CHLORZOXAZONE	CHLORZOXAZONE	250MG	TABLET;ORAL	Prescription	No	AA	214702	COREPHARMA
CHLORZOXAZONE	CHLORZOXAZONE	250MG	TABLET;ORAL	Prescription	No	AA	216925	RISING
CHLORZOXAZONE	CHLORZOXAZONE	250MG	TABLET;ORAL	Prescription	No	AA	215158	SENORES PHARMS

Top