Details for New Drug Application (NDA): 021660
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NDA 021660 describes ABRAXANE, which is a drug marketed by Bristol-myers and is included in one NDA. It is available from three suppliers. There are eleven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ABRAXANE profile page.
The generic ingredient in ABRAXANE is paclitaxel. There are sixty-nine drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the paclitaxel profile page.
The generic ingredient in ABRAXANE is paclitaxel. There are sixty-nine drug master file entries for this compound. Seventeen 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 |
| Formulation / Manufacturing: | see details |
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: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 6, 2023 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 21, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 27, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bristol-myers | ABRAXANE | paclitaxel | POWDER;INTRAVENOUS | 021660-001 | Jan 7, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bristol-myers | ABRAXANE | paclitaxel | POWDER;INTRAVENOUS | 021660-001 | Jan 7, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bristol-myers | ABRAXANE | paclitaxel | POWDER;INTRAVENOUS | 021660-001 | Jan 7, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bristol-myers | ABRAXANE | paclitaxel | POWDER;INTRAVENOUS | 021660-001 | Jan 7, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bristol-myers | ABRAXANE | paclitaxel | POWDER;INTRAVENOUS | 021660-001 | Jan 7, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bristol-myers | ABRAXANE | paclitaxel | POWDER;INTRAVENOUS | 021660-001 | Jan 7, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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