Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203695
Company: ACTAVIS LABS FL INC

Products on ANDA 203695

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METAXALONE	METAXALONE	800MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203695

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/15/2017	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
04/26/2023	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203695

METAXALONE

TABLET;ORAL; 800MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METAXALONE	METAXALONE	800MG	TABLET;ORAL	Prescription	No	AB	203695	ACTAVIS LABS FL INC
METAXALONE	METAXALONE	800MG	TABLET;ORAL	Prescription	No	AB	203399	AMNEAL PHARMS
METAXALONE	METAXALONE	800MG	TABLET;ORAL	Prescription	No	AB	204770	LANNETT CO INC
METAXALONE	METAXALONE	800MG	TABLET;ORAL	Prescription	No	AB	040445	SANDOZ
METAXALONE	METAXALONE	800MG	TABLET;ORAL	Prescription	No	AB	207466	SCIEGEN PHARMS INC