Details for New Drug Application (NDA): 201195
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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 201195
Tradename: | DOCETAXEL |
Applicant: | Accord Hlthcare |
Ingredient: | docetaxel |
Patents: | 0 |
Pharmacology for NDA: 201195
Physiological Effect | Microtubule Inhibition |
Suppliers and Packaging for NDA: 201195
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOCETAXEL | docetaxel | INJECTABLE;INJECTION | 201195 | NDA | Accord Healthcare Inc. | 16729-267 | 16729-267-63 | 1 VIAL, MULTI-DOSE in 1 CARTON (16729-267-63) / 1 mL in 1 VIAL, MULTI-DOSE |
DOCETAXEL | docetaxel | INJECTABLE;INJECTION | 201195 | NDA | Accord Healthcare Inc. | 16729-267 | 16729-267-64 | 1 VIAL, MULTI-DOSE in 1 CARTON (16729-267-64) / 4 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/0.5ML (40MG/ML) | ||||
Approval Date: | Jun 8, 2011 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 80MG/2ML (40MG/ML) | ||||
Approval Date: | Jun 8, 2011 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/ML (20MG/ML) | ||||
Approval Date: | Apr 20, 2012 | TE: | AP | RLD: | Yes |
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