Details for New Drug Application (NDA): 215744
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NDA 215744 describes DOCETAXEL, which is a drug marketed by Accord Hlthcare, Actavis, Alembic, Amneal, Apotex Inc, Dfb Oncology Ltd, Dr Reddys, Eugia Pharma, Gland, Guangdong Sunho, Hengrui Pharma, Heritage, Hikma, Hospira Inc, Meitheal, Mylan Labs Ltd, Novast Labs, Pfizer Labs, Pharmobedient, Sandoz, Shilpa, Sun Pharm, and Teva Pharms Usa, and is included in twenty-eight NDAs. It is available from twenty-one suppliers. There are four patents protecting this drug. Additional details are available on the DOCETAXEL profile page.
The generic ingredient in DOCETAXEL is docetaxel. There are forty-one drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the docetaxel profile page.
The generic ingredient in DOCETAXEL is docetaxel. There are forty-one drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the docetaxel profile page.
Pharmacology for NDA: 215744
| Physiological Effect | Microtubule Inhibition |
Suppliers and Packaging for NDA: 215744
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOCETAXEL | docetaxel | INJECTABLE;INJECTION | 215744 | ANDA | Baxter Healthcare Corporation | 43066-044 | 43066-044-02 | 1 VIAL, SINGLE-DOSE in 1 CARTON (43066-044-02) / 2 mL in 1 VIAL, SINGLE-DOSE (43066-044-01) |
| DOCETAXEL | docetaxel | INJECTABLE;INJECTION | 215744 | ANDA | Baxter Healthcare Corporation | 43066-046 | 43066-046-08 | 1 VIAL, MULTI-DOSE in 1 CARTON (43066-046-08) / 8 mL in 1 VIAL, MULTI-DOSE (43066-046-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/2ML (10MG/ML) | ||||
| Approval Date: | Feb 28, 2023 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 80MG/8ML (10MG/ML) | ||||
| Approval Date: | Feb 28, 2023 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 160MG/16ML (10MG/ML) | ||||
| Approval Date: | Feb 28, 2023 | TE: | AP | RLD: | No | ||||
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