Details for New Drug Application (NDA): 201525
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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 201525
Tradename: | DOCETAXEL |
Applicant: | Sandoz |
Ingredient: | docetaxel |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 201525
Physiological Effect | Microtubule Inhibition |
Suppliers and Packaging for NDA: 201525
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOCETAXEL | docetaxel | INJECTABLE;INJECTION | 201525 | NDA | Baxter Healthcare Corporation | 43066-001 | 43066-001-01 | 1 VIAL, MULTI-DOSE in 1 CARTON (43066-001-01) / 2 mL in 1 VIAL, MULTI-DOSE |
DOCETAXEL | docetaxel | INJECTABLE;INJECTION | 201525 | NDA | Baxter Healthcare Corporation | 43066-006 | 43066-006-01 | 1 VIAL, MULTI-DOSE in 1 CARTON (43066-006-01) / 8 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/2ML (10MG/ML) | ||||
Approval Date: | Jun 29, 2011 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 80MG/8ML (10MG/ML) | ||||
Approval Date: | Jun 29, 2011 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 160MG/16ML (10MG/ML) | ||||
Approval Date: | Jun 29, 2011 | TE: | AP | RLD: | No |
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