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Last Updated: July 13, 2024

Suppliers and packages for generic ingredient: TEMSIROLIMUS


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TEMSIROLIMUS

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Accord Hlthcare TEMSIROLIMUS temsirolimus SOLUTION;INTRAVENOUS 203153 ANDA Accord Healthcare Inc. 16729-223-61 1 KIT in 1 KIT (16729-223-61) * 1 mL in 1 VIAL, SINGLE-DOSE (16729-221-30) * 1.8 mL in 1 VIAL, SINGLE-DOSE (16729-222-30) 2018-08-13
Gland Pharma Ltd TEMSIROLIMUS temsirolimus SOLUTION;INTRAVENOUS 207383 ANDA Fresenius Kabi USA, LLC 65219-200-05 1 KIT in 1 KIT (65219-200-05) * 1 mL in 1 VIAL, SINGLE-DOSE (65219-205-05) * 1.8 mL in 1 VIAL, SINGLE-DOSE (65219-202-05) 2020-11-20
Gland Pharma Ltd TEMSIROLIMUS temsirolimus SOLUTION;INTRAVENOUS 207383 ANDA Gland Pharma Limited 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) 2019-08-26
Gland Pharma Ltd TEMSIROLIMUS temsirolimus SOLUTION;INTRAVENOUS 207383 ANDA Almaject, Inc. 72611-785-02 1 KIT in 1 CARTON (72611-785-02) * 1 mL in 1 VIAL, SINGLE-DOSE (72611-780-01) * 1.8 mL in 1 VIAL, SINGLE-DOSE (72611-782-01) 2020-05-08
Pf Prism Cv TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088 NDA Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 0008-1179-01 1 KIT in 1 CARTON (0008-1179-01) * 25 mL in 1 VIAL, SINGLE-USE (0008-1279-01) * 1.8 mL in 1 VIAL, SINGLE-USE (0008-1125-01) 2007-07-01
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

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