Details for New Drug Application (NDA): 022275
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The generic ingredient in SAMSCA is tolvaptan. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the tolvaptan profile page.
Pharmacology for NDA: 022275
Mechanism of Action | Vasopressin V2 Receptor Antagonists |
Suppliers and Packaging for NDA: 022275
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SAMSCA | tolvaptan | TABLET;ORAL | 022275 | NDA | Otsuka America Pharmaceutical, Inc. | 59148-020 | 59148-020-50 | 1 BLISTER PACK in 1 CARTON (59148-020-50) / 10 TABLET in 1 BLISTER PACK |
SAMSCA | tolvaptan | TABLET;ORAL | 022275 | NDA | Otsuka America Pharmaceutical, Inc. | 59148-021 | 59148-021-50 | 1 BLISTER PACK in 1 CARTON (59148-021-50) / 10 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
Approval Date: | May 19, 2009 | TE: | AB | RLD: | Yes | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 7, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Sep 1, 2026 | Product Flag? | Substance Flag? | Y | Delist Request? |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
Approval Date: | May 19, 2009 | TE: | AB | RLD: | Yes | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 7, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 022275
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Otsuka | SAMSCA | tolvaptan | TABLET;ORAL | 022275-001 | May 19, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Otsuka | SAMSCA | tolvaptan | TABLET;ORAL | 022275-002 | May 19, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Otsuka | SAMSCA | tolvaptan | TABLET;ORAL | 022275-003 | May 19, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Otsuka | SAMSCA | tolvaptan | TABLET;ORAL | 022275-003 | May 19, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Otsuka | SAMSCA | tolvaptan | TABLET;ORAL | 022275-002 | May 19, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Otsuka | SAMSCA | tolvaptan | TABLET;ORAL | 022275-001 | May 19, 2009 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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