Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203153
Company: ACCORD HLTHCARE

Products on ANDA 203153

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TEMSIROLIMUS	TEMSIROLIMUS	25MG/ML (25MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203153

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/30/2018	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203153Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 203153

TEMSIROLIMUS

SOLUTION;INTRAVENOUS; 25MG/ML (25MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TEMSIROLIMUS	TEMSIROLIMUS	25MG/ML (25MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	203153	ACCORD HLTHCARE
TEMSIROLIMUS	TEMSIROLIMUS	25MG/ML (25MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	207383	GLAND PHARMA LTD
TORISEL	TEMSIROLIMUS	25MG/ML (25MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	022088	PF PRISM CV