Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040486
Company: MOUNTAIN

Products on ANDA 040486

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METAXALONE	METAXALONE	400MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040486

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/27/2015	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/040486Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/23/2025	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
10/07/2019	SUPPL-7	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 040486

METAXALONE

TABLET;ORAL; 400MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METAXALONE	METAXALONE	400MG	TABLET;ORAL	Prescription	No	AB	040486	MOUNTAIN
METAXALONE	METAXALONE	400MG	TABLET;ORAL	Prescription	No	AB	207466	SCIEGEN PHARMS