Details for New Drug Application (NDA): 207252
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The generic ingredient in DOCETAXEL is docetaxel. There are forty-one drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the docetaxel profile page.
Summary for 207252
Tradename: | DOCETAXEL |
Applicant: | Hengrui Pharma |
Ingredient: | docetaxel |
Patents: | 0 |
Pharmacology for NDA: 207252
Physiological Effect | Microtubule Inhibition |
Suppliers and Packaging for NDA: 207252
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOCETAXEL | docetaxel | INJECTABLE;INJECTION | 207252 | ANDA | Sagent Pharmaceuticals | 25021-245 | 25021-245-01 | 1 VIAL in 1 CARTON (25021-245-01) / 1 mL in 1 VIAL |
DOCETAXEL | docetaxel | INJECTABLE;INJECTION | 207252 | ANDA | Sagent Pharmaceuticals | 25021-245 | 25021-245-04 | 1 VIAL in 1 CARTON (25021-245-04) / 4 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/ML (20MG/ML) | ||||
Approval Date: | Aug 9, 2017 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 80MG/4ML (20MG/ML) | ||||
Approval Date: | Aug 9, 2017 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 160MG/8ML (20MG/ML) | ||||
Approval Date: | Aug 9, 2017 | TE: | AP | RLD: | No |
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