Details for New Drug Application (NDA): 021660
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The generic ingredient in ABRAXANE 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 021660
Tradename: | ABRAXANE |
Applicant: | Bristol-myers |
Ingredient: | paclitaxel |
Patents: | 11 |
Pharmacology for NDA: 021660
Physiological Effect | Microtubule Inhibition |
Medical Subject Heading (MeSH) Categories for 021660
Suppliers and Packaging for NDA: 021660
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ABRAXANE | paclitaxel | POWDER;INTRAVENOUS | 021660 | NDA AUTHORIZED GENERIC | TWi Pharmaceuticals, Inc. | 24979-710 | 24979-710-51 | 1 VIAL, SINGLE-USE in 1 CARTON (24979-710-51) / 20 mL in 1 VIAL, SINGLE-USE |
ABRAXANE | paclitaxel | POWDER;INTRAVENOUS | 021660 | NDA AUTHORIZED GENERIC | Apotex Corp. | 60505-6230 | 60505-6230-4 | 1 VIAL, SINGLE-USE in 1 CARTON (60505-6230-4) / 20 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 100MG/VIAL | ||||
Approval Date: | Jan 7, 2005 | TE: | AB | RLD: | Yes | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 21, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 27, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 9, 2024 | Product Flag? | Substance Flag? | Delist Request? |
Expired US Patents for NDA 021660
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bristol-myers | ABRAXANE | paclitaxel | POWDER;INTRAVENOUS | 021660-001 | Jan 7, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Bristol-myers | ABRAXANE | paclitaxel | POWDER;INTRAVENOUS | 021660-001 | Jan 7, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Bristol-myers | ABRAXANE | paclitaxel | POWDER;INTRAVENOUS | 021660-001 | Jan 7, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Bristol-myers | ABRAXANE | paclitaxel | POWDER;INTRAVENOUS | 021660-001 | Jan 7, 2005 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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