Details for New Drug Application (NDA): 021060
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NDA 021060 describes PRIALT, which is a drug marketed by Tersera and is included in one NDA. It is available from one supplier. Additional details are available on the PRIALT profile page.
The generic ingredient in PRIALT is ziconotide acetate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ziconotide acetate profile page.
The generic ingredient in PRIALT is ziconotide acetate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ziconotide acetate profile page.
Summary for 021060
| Tradename: | PRIALT |
| Applicant: | Tersera |
| Ingredient: | ziconotide acetate |
| Patents: | 0 |
Pharmacology for NDA: 021060
| Mechanism of Action | N-Calcium Channel Receptor Antagonists |
Suppliers and Packaging for NDA: 021060
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060 | NDA | TerSera Therapeutics LLC | 70720-720 | 70720-720-10 | 1 VIAL, GLASS in 1 CARTON (70720-720-10) / 1 mL in 1 VIAL, GLASS |
| PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060 | NDA | TerSera Therapeutics LLC | 70720-722 | 70720-722-10 | 1 VIAL, GLASS in 1 CARTON (70720-722-10) / 5 mL in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRATHECAL | Strength | 500MCG/20ML (25MCG/ML) | ||||
| Approval Date: | Dec 28, 2004 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRATHECAL | Strength | 100MCG/1ML (100MCG/ML) | ||||
| Approval Date: | Dec 28, 2004 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRATHECAL | Strength | 200MCG/2ML (100MCG/ML) | ||||
| Approval Date: | Dec 28, 2004 | TE: | RLD: | No | |||||
Expired US Patents for NDA 021060
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Tersera | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-001 | Dec 28, 2004 | 8,653,033 | ⤷ Start Trial |
| Tersera | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-004 | Dec 28, 2004 | 8,765,680 | ⤷ Start Trial |
| Tersera | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-003 | Dec 28, 2004 | 9,707,270 | ⤷ Start Trial |
| Tersera | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-002 | Dec 28, 2004 | 5,364,842 | ⤷ Start Trial |
| Tersera | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-003 | Dec 28, 2004 | 8,653,033 | ⤷ Start Trial |
| Tersera | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-001 | Dec 28, 2004 | 5,364,842 | ⤷ Start Trial |
| Tersera | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-004 | Dec 28, 2004 | 5,859,186 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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