Details for New Drug Application (NDA): 213510
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The generic ingredient in DOCETAXEL is docetaxel. There are forty-one drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the docetaxel profile page.
Summary for 213510
Tradename: | DOCETAXEL |
Applicant: | Gland Pharma Ltd |
Ingredient: | docetaxel |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 213510
Physiological Effect | Microtubule Inhibition |
Suppliers and Packaging for NDA: 213510
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOCETAXEL | docetaxel | INJECTABLE;INJECTION | 213510 | ANDA | Sagent Pharmaceuticals | 25021-254 | 25021-254-08 | 1 VIAL in 1 CARTON (25021-254-08) / 8 mL in 1 VIAL |
DOCETAXEL | docetaxel | INJECTABLE;INJECTION | 213510 | ANDA | Sagent Pharmaceuticals | 25021-254 | 25021-254-16 | 1 VIAL in 1 CARTON (25021-254-16) / 16 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/2ML (10MG/ML) | ||||
Approval Date: | Jul 1, 2021 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 80MG/8ML (10MG/ML) | ||||
Approval Date: | Jul 1, 2021 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 160MG/16ML (10MG/ML) | ||||
Approval Date: | Jul 1, 2021 | TE: | AP | RLD: | No |
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