Details for New Drug Application (NDA): 204485
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The generic ingredient in VASOSTRICT is vasopressin. There are nine drug master file entries for this compound. Fifteen 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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