Details for New Drug Application (NDA): 216874
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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 216874
Tradename: | PACLITAXEL |
Applicant: | Alembic |
Ingredient: | paclitaxel |
Patents: | 0 |
Pharmacology for NDA: 216874
Physiological Effect | Microtubule Inhibition |
Medical Subject Heading (MeSH) Categories for 216874
Suppliers and Packaging for NDA: 216874
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PACLITAXEL | paclitaxel | INJECTABLE;INJECTION | 216874 | ANDA | Alembic Pharmaceuticals Limited | 46708-620 | 46708-620-05 | 1 VIAL, MULTI-DOSE in 1 CARTON (46708-620-05) / 5 mL in 1 VIAL, MULTI-DOSE |
PACLITAXEL | paclitaxel | INJECTABLE;INJECTION | 216874 | ANDA | Alembic Pharmaceuticals Limited | 46708-621 | 46708-621-17 | 1 VIAL, MULTI-DOSE in 1 CARTON (46708-621-17) / 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: | Oct 20, 2022 | TE: | AP | RLD: | No |
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