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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215541
Company: LEADING

Products on ANDA 215541

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METYROSINE	METYROSINE	250MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215541

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/17/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 215541

METYROSINE

CAPSULE;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEMSER	METYROSINE	250MG	CAPSULE;ORAL	Prescription	Yes	AB	017871	BAUSCH
METYROSINE	METYROSINE	250MG	CAPSULE;ORAL	Prescription	No	AB	213734	AMNEAL
METYROSINE	METYROSINE	250MG	CAPSULE;ORAL	Prescription	No	AB	218620	DR REDDYS LABS SA
METYROSINE	METYROSINE	250MG	CAPSULE;ORAL	Prescription	No	AB	215541	LEADING

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