Details for New Drug Application (NDA): 207326
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The generic ingredient in PACLITAXEL is paclitaxel. There are sixty-nine drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the paclitaxel profile page.
Summary for 207326
Tradename: | PACLITAXEL |
Applicant: | Gland Pharma Ltd |
Ingredient: | paclitaxel |
Patents: | 0 |
Pharmacology for NDA: 207326
Physiological Effect | Microtubule Inhibition |
Medical Subject Heading (MeSH) Categories for 207326
Suppliers and Packaging for NDA: 207326
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PACLITAXEL | paclitaxel | INJECTABLE;INJECTION | 207326 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-882 | 23155-882-31 | 1 VIAL, MULTI-DOSE in 1 CARTON (23155-882-31) / 5 mL in 1 VIAL, MULTI-DOSE |
PACLITAXEL | paclitaxel | INJECTABLE;INJECTION | 207326 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-883 | 23155-883-31 | 1 VIAL, MULTI-DOSE in 1 CARTON (23155-883-31) / 16.7 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 6MG/ML | ||||
Approval Date: | Aug 23, 2016 | TE: | AP | RLD: | No |
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