Details for New Drug Application (NDA): 021060
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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: | 3 |
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 | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Oct 1, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | ANALGESIA | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Oct 1, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF PAIN | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Oct 1, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | ANALGESIA |
Expired US Patents for NDA 021060
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Tersera | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-003 | Dec 28, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Tersera | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-002 | Dec 28, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Tersera | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-003 | Dec 28, 2004 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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