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 four 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. Five suppliers are listed for this compound. 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. Five 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 |
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 | Fresenius Kabi USA, LLC | 65219-200 | 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) |
| 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: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 25MG/ML (25MG/ML) | ||||
| Approval Date: | Aug 16, 2019 | TE: | AP | RLD: | No | ||||
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