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Last Updated: November 22, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207383

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NDA 207383 describes TEMSIROLIMUS, which is a drug marketed by Accord Hlthcare and Gland Pharma Ltd and is included in two NDAs. It is available from two suppliers. Additional details are available on the TEMSIROLIMUS profile page.

The generic ingredient in TEMSIROLIMUS is temsirolimus. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the temsirolimus profile page.
Summary for 207383
Tradename:TEMSIROLIMUS
Applicant:Gland Pharma Ltd
Ingredient:temsirolimus
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 207383
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TEMSIROLIMUS temsirolimus SOLUTION;INTRAVENOUS 207383 ANDA Gland Pharma Limited 68083-202 68083-202-01 1 KIT in 1 CARTON (68083-202-01) * 1 mL in 1 VIAL, SINGLE-USE (68083-200-01) * 1.8 mL in 1 VIAL, SINGLE-USE (68083-201-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength25MG/ML (25MG/ML)
Approval Date:Aug 16, 2019TE:APRLD:No

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