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): 040792
Company: AUROBINDO PHARMA

Products on ANDA 040792

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CARISOPRODOL	CARISOPRODOL	350MG	TABLET;ORAL	Prescription	AA	No	No
CARISOPRODOL	CARISOPRODOL	250MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040792

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/06/2009	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
11/13/2018	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
10/26/2018	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
04/30/2013	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
11/08/2016	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
05/02/2013	SUPPL-4	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
03/03/2010	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
03/10/2010	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 040792

CARISOPRODOL

TABLET;ORAL; 350MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARISOPRODOL	CARISOPRODOL	350MG	TABLET;ORAL	Prescription	No	AA	040576	ACCELRX LABS
CARISOPRODOL	CARISOPRODOL	350MG	TABLET;ORAL	Prescription	No	AA	040792	AUROBINDO PHARMA
CARISOPRODOL	CARISOPRODOL	350MG	TABLET;ORAL	Prescription	No	AA	040245	CHARTWELL RX
CARISOPRODOL	CARISOPRODOL	350MG	TABLET;ORAL	Prescription	No	AA	211789	MLV
CARISOPRODOL	CARISOPRODOL	350MG	TABLET;ORAL	Prescription	No	AA	090988	NATCO
CARISOPRODOL	CARISOPRODOL	350MG	TABLET;ORAL	Prescription	No	AA	207237	NOSTRUM LABS INC
CARISOPRODOL	CARISOPRODOL	350MG	TABLET;ORAL	Prescription	No	AA	040823	NOVAST LABS
CARISOPRODOL	CARISOPRODOL	350MG	TABLET;ORAL	Prescription	No	AA	205085	ORIENT PHARMA CO LTD
CARISOPRODOL	CARISOPRODOL	350MG	TABLET;ORAL	Prescription	No	AA	040188	OXFORD PHARMS
CARISOPRODOL	CARISOPRODOL	350MG	TABLET;ORAL	Prescription	No	AA	203374	SCIEGEN PHARMS INC
CARISOPRODOL	CARISOPRODOL	350MG	TABLET;ORAL	Prescription	No	AA	081025	WANBANG BIOPHARMS
CARISOPRODOL	CARISOPRODOL	350MG	TABLET;ORAL	Prescription	No	AA	087499	WATSON LABS
CARISOPRODOL	CARISOPRODOL	350MG	TABLET;ORAL	Prescription	No	AA	205126	WILSHIRE PHARMS INC
SOMA	CARISOPRODOL	350MG	TABLET;ORAL	Prescription	Yes	AA	011792	MYLAN SPECIALITY LP

TABLET;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARISOPRODOL	CARISOPRODOL	250MG	TABLET;ORAL	Prescription	No	AB	040792	AUROBINDO PHARMA
CARISOPRODOL	CARISOPRODOL	250MG	TABLET;ORAL	Prescription	No	AB	207237	NOSTRUM LABS INC
CARISOPRODOL	CARISOPRODOL	250MG	TABLET;ORAL	Prescription	No	AB	205126	WILSHIRE PHARMS INC
SOMA	CARISOPRODOL	250MG	TABLET;ORAL	Prescription	Yes	AB	011792	MYLAN SPECIALITY LP

Top