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 |
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