Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 040489
Company: OXFORD PHARMS

Products on ANDA 040489

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET;ORAL	Prescription	AA	No	No
METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040489

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/29/2003	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
07/02/2020	SUPPL-15	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
05/05/2005	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 040489

METHOCARBAMOL

TABLET;ORAL; 500MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET;ORAL	Prescription	No	AA	213967	AUROBINDO PHARMA LTD
METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET;ORAL	Prescription	No	AA	208507	BEXIMCO PHARMS USA
METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET;ORAL	Prescription	No	AA	203550	DBL PHARMS
METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET;ORAL	Prescription	No	AA	209312	GRANULES
METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET;ORAL	Prescription	No	AA	200958	HANGZHOU BINJIANG
METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET;ORAL	Prescription	No	AA	090200	HETERO LABS LTD III
METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET;ORAL	Prescription	No	AA	212623	MLV
METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET;ORAL	Prescription	No	AA	040489	OXFORD PHARMS
METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET;ORAL	Prescription	No	AA	086988	PRINSTON INC

TABLET;ORAL; 750MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET;ORAL	Prescription	No	AA	213967	AUROBINDO PHARMA LTD
METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET;ORAL	Prescription	No	AA	208507	BEXIMCO PHARMS USA
METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET;ORAL	Prescription	No	AA	203550	DBL PHARMS
METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET;ORAL	Prescription	No	AA	209312	GRANULES
METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET;ORAL	Prescription	No	AA	200958	HANGZHOU BINJIANG
METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET;ORAL	Prescription	No	AA	090200	HETERO LABS LTD III
METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET;ORAL	Prescription	No	AA	212623	MLV
METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET;ORAL	Prescription	No	AA	040489	OXFORD PHARMS
METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET;ORAL	Prescription	No	AA	086988	PRINSTON INC