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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040245
Company: CHARTWELL RX

Products on ANDA 040245

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040245

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/08/1997	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
07/26/2013	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
05/24/2011	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
01/29/2009	SUPPL-5	Labeling		Label is not available on this site.
11/29/2006	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 040245

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

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