Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040445
Company: SANDOZ

Products on ANDA 040445

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 040445

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/31/2010	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/040445s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/040445Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/25/2023	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
01/10/2013	SUPPL-3	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2013/040445Orig1s003Approv.pdf

Therapeutic Equivalents for ANDA 040445

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