Details for New Drug Application (NDA): 207563
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NDA 207563 describes DOCETAXEL, which is a drug marketed by Accord Hlthcare, Actavis, Alembic, Amneal, Apotex Inc, Dfb Oncology Ltd, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Hengrui Pharma, Heritage, Hikma, Hospira Inc, Meitheal, Mylan Labs Ltd, Norvium Bioscience, Novast Labs, Pfizer Labs, Sandoz, Shilpa, Sun Pharm, and Teva Pharms Usa, and is included in twenty-seven NDAs. It is available from nineteen 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 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 suppliers are listed for this compound. Additional details are available on the docetaxel profile page.
Summary for 207563
| Tradename: | DOCETAXEL |
| Applicant: | Novast Labs |
| Ingredient: | docetaxel |
| Patents: | 0 |
Pharmacology for NDA: 207563
| Physiological Effect | Microtubule Inhibition |
Suppliers and Packaging for NDA: 207563
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOCETAXEL | docetaxel | INJECTABLE;INJECTION | 207563 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-431 | 50742-431-08 | 1 VIAL, MULTI-DOSE in 1 CARTON (50742-431-08) / 8 mL in 1 VIAL, MULTI-DOSE |
| DOCETAXEL | docetaxel | INJECTABLE;INJECTION | 207563 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-463 | 50742-463-16 | 1 VIAL, MULTI-DOSE in 1 CARTON (50742-463-16) / 16 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/2ML (10MG/ML) | ||||
| Approval Date: | Aug 31, 2017 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 80MG/8ML (10MG/ML) | ||||
| Approval Date: | Aug 31, 2017 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 160MG/16ML (10MG/ML) | ||||
| Approval Date: | Aug 31, 2017 | TE: | AP | RLD: | No | ||||
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