Details for New Drug Application (NDA): 204485
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NDA 204485 describes VASOSTRICT, which is a drug marketed by Endo Operations and is included in one NDA. It is available from five suppliers. There are fourteen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the VASOSTRICT profile page.
The generic ingredient in VASOSTRICT is vasopressin. There are nine drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the vasopressin profile page.
The generic ingredient in VASOSTRICT is vasopressin. There are nine drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the vasopressin profile page.
Summary for 204485
| Tradename: | VASOSTRICT |
| Applicant: | Endo Operations |
| Ingredient: | vasopressin |
| Patents: | 14 |
Suppliers and Packaging for NDA: 204485
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VASOSTRICT | vasopressin | SOLUTION;INTRAVENOUS | 204485 | NDA | ENDO USA, Inc. | 42023-164 | 42023-164-10 | 10 VIAL in 1 CARTON (42023-164-10) / 1 mL in 1 VIAL (42023-164-01) |
| VASOSTRICT | vasopressin | SOLUTION;INTRAVENOUS | 204485 | NDA | ENDO USA, Inc. | 42023-164 | 42023-164-25 | 25 VIAL in 1 CARTON (42023-164-25) / 1 mL in 1 VIAL (42023-164-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 20UNITS/ML (20UNITS/ML) | ||||
| Approval Date: | Apr 17, 2014 | TE: | AP | RLD: | Yes | ||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jan 30, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TO INCREASE BLOOD PRESSURE IN ADULTS WITH VASODILATORY SHOCK (E.G., POST-CARDIOTOMY OR SEPSIS) WHO REMAIN HYPOTENSIVE DESPITE FLUIDS AND CATECHOLAMINES | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jan 30, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TO INCREASE BLOOD PRESSURE IN ADULTS WITH VASODILATORY SHOCK (E.G., POST-CARDIOTOMY OR SEPSIS) WHO REMAIN HYPOTENSIVE DESPITE FLUIDS AND CATECHOLAMINES | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jan 30, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TO INCREASE BLOOD PRESSURE IN ADULTS WITH VASODILATORY SHOCK (E.G., POST-CARDIOTOMY OR SEPSIS) WHO REMAIN HYPOTENSIVE DESPITE FLUIDS AND CATECHOLAMINES | ||||||||
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