Details for New Drug Application (NDA): 021602
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NDA 021602 describes VELCADE, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the VELCADE profile page.
The generic ingredient in VELCADE is bortezomib. There are twenty drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the bortezomib profile page.
The generic ingredient in VELCADE is bortezomib. There are twenty drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the bortezomib profile page.
Summary for 021602
| Tradename: | VELCADE |
| Applicant: | Takeda Pharms Usa |
| Ingredient: | bortezomib |
| Patents: | 2 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021602
| Mechanism of Action | Proteasome Inhibitors |
Medical Subject Heading (MeSH) Categories for 021602
Suppliers and Packaging for NDA: 021602
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VELCADE | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021602 | NDA | Takeda Pharmaceuticals America, Inc. | 63020-049 | 63020-049-01 | 1 VIAL in 1 CARTON (63020-049-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Strength | 3.5MG/VIAL | ||||
| Approval Date: | May 13, 2003 | TE: | AP | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Apr 8, 2022 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Patent: | See Plans and Pricing | Patent Expiration: | Jul 25, 2022 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | See Plans and Pricing | Patent Expiration: | Jul 25, 2022 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 021602
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Takeda Pharms Usa | VELCADE | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021602-001 | May 13, 2003 | See Plans and Pricing | See Plans and Pricing |
| Takeda Pharms Usa | VELCADE | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021602-001 | May 13, 2003 | See Plans and Pricing | See Plans and Pricing |
| Takeda Pharms Usa | VELCADE | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021602-001 | May 13, 2003 | See Plans and Pricing | See Plans and Pricing |
| Takeda Pharms Usa | VELCADE | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021602-001 | May 13, 2003 | See Plans and Pricing | See Plans and Pricing |
| Takeda Pharms Usa | VELCADE | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021602-001 | May 13, 2003 | See Plans and Pricing | See Plans and Pricing |
| Takeda Pharms Usa | VELCADE | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021602-001 | May 13, 2003 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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