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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211504
Company: GLAND PHARMA LTD

Products on ANDA 211504

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHOCARBAMOL	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION;IM-IV	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211504

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/26/2018	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
08/04/2020	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 211504

METHOCARBAMOL

SOLUTION;IM-IV; 1GM/10ML (100MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHOCARBAMOL	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION;IM-IV	Prescription	No	AP	207496	AM REGENT
METHOCARBAMOL	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION;IM-IV	Prescription	No	AP	206128	EUGIA PHARMA
METHOCARBAMOL	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION;IM-IV	Prescription	No	AP	209331	FRESENIUS KABI USA
METHOCARBAMOL	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION;IM-IV	Prescription	No	AP	211504	GLAND PHARMA LTD
METHOCARBAMOL	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION;IM-IV	Prescription	No	AP	205354	MONTEREY PHARMS LLC
METHOCARBAMOL	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION;IM-IV	Prescription	No	AP	206071	NAVINTA LLC
METHOCARBAMOL	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION;IM-IV	Prescription	No	AP	205404	SAGENT PHARMS INC
METHOCARBAMOL	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION;IM-IV	Prescription	No	AP	208116	SLATE RUN PHARMA
METHOCARBAMOL	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION;IM-IV	Prescription	No	AP	207522	SOMERSET THERAPS LLC
ROBAXIN	METHOCARBAMOL	1GM/10ML (100MG/ML)	SOLUTION;IM-IV	Prescription	Yes	AP	011790	HIKMA

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