Details for New Drug Application (NDA): 204193
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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 204193
Tradename: | DOCETAXEL |
Applicant: | Dr Reddys |
Ingredient: | docetaxel |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204193
Physiological Effect | Microtubule Inhibition |
Suppliers and Packaging for NDA: 204193
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOCETAXEL | docetaxel | INJECTABLE;INJECTION | 204193 | ANDA | Dr. Reddy's Laboratories Inc. | 43598-258 | 43598-258-11 | 1 mL in 1 VIAL, GLASS (43598-258-11) |
DOCETAXEL | docetaxel | INJECTABLE;INJECTION | 204193 | ANDA | Dr. Reddy's Laboratories Inc. | 43598-259 | 43598-259-40 | 4 mL in 1 VIAL, GLASS (43598-259-40) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/ML (20MG/ML) | ||||
Approval Date: | Nov 5, 2014 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 80MG/4ML (20MG/ML) | ||||
Approval Date: | Nov 5, 2014 | TE: | AP | RLD: | No |
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