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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216076
Company: TEVA PHARMS

Products on ANDA 216076

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MIDOSTAURIN	MIDOSTAURIN	25MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216076

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/29/2024	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/216076Orig1s000TAltr.pdf

Therapeutic Equivalents for ANDA 216076

MIDOSTAURIN

CAPSULE;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MIDOSTAURIN	MIDOSTAURIN	25MG	CAPSULE;ORAL	Prescription	No	AB	216015	LUPIN
MIDOSTAURIN	MIDOSTAURIN	25MG	CAPSULE;ORAL	Prescription	No	AB	216076	TEVA PHARMS
RYDAPT	MIDOSTAURIN	25MG	CAPSULE;ORAL	Prescription	Yes	AB	207997	NOVARTIS

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