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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216728
Company: MSN

Products on ANDA 216728

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SIROLIMUS	SIROLIMUS	1MG/ML	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216728

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/19/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216728

SIROLIMUS

SOLUTION;ORAL; 1MG/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RAPAMUNE	SIROLIMUS	1MG/ML	SOLUTION;ORAL	Prescription	Yes	AA	021083	PF PRISM CV
SIROLIMUS	SIROLIMUS	1MG/ML	SOLUTION;ORAL	Prescription	No	AA	211212	AMNEAL
SIROLIMUS	SIROLIMUS	1MG/ML	SOLUTION;ORAL	Prescription	No	AA	211406	APOTEX
SIROLIMUS	SIROLIMUS	1MG/ML	SOLUTION;ORAL	Prescription	No	AA	216728	MSN
SIROLIMUS	SIROLIMUS	1MG/ML	SOLUTION;ORAL	Prescription	No	AA	211040	NOVITIUM PHARMA

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