Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209312
Company: GRANULES

Products on ANDA 209312

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209312

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/07/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/14/2020	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
07/14/2020	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 209312

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	200958	BOSTAL
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	090200	HETERO LABS LTD III
METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET;ORAL	Prescription	No	AA	040489	OXFORD PHARMS
METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET;ORAL	Prescription	No	AA	212623	POINTVIEW HLDINGS
METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET;ORAL	Prescription	No	AA	086988	PRINSTON INC
METHOCARBAMOL	METHOCARBAMOL	500MG	TABLET;ORAL	Prescription	No	AA	208507	REGCON HOLDINGS

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	200958	BOSTAL
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	090200	HETERO LABS LTD III
METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET;ORAL	Prescription	No	AA	040489	OXFORD PHARMS
METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET;ORAL	Prescription	No	AA	212623	POINTVIEW HLDINGS
METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET;ORAL	Prescription	No	AA	086988	PRINSTON INC
METHOCARBAMOL	METHOCARBAMOL	750MG	TABLET;ORAL	Prescription	No	AA	208507	REGCON HOLDINGS