Details for New Drug Application (NDA): 216963
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NDA 216963 describes VASOPRESSIN IN DEXTROSE 5%, which is a drug marketed by Gland and is included in one NDA. It is available from two suppliers. Additional details are available on the VASOPRESSIN IN DEXTROSE 5% profile page.
The generic ingredient in VASOPRESSIN IN DEXTROSE 5% is vasopressin. There are nine drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the vasopressin profile page.
The generic ingredient in VASOPRESSIN IN DEXTROSE 5% is vasopressin. There are nine drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the vasopressin profile page.
Summary for 216963
| Tradename: | VASOPRESSIN IN DEXTROSE 5% |
| Applicant: | Gland |
| Ingredient: | vasopressin |
| Patents: | 0 |
Pharmacology for NDA: 216963
| Physiological Effect | Decreased Diuresis Vasoconstriction |
Suppliers and Packaging for NDA: 216963
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VASOPRESSIN | vasopressin | SOLUTION;INTRAVENOUS | 216963 | ANDA | Sagent Pharmaceuticals | 25021-474 | 25021-474-01 | 25 VIAL in 1 CARTON (25021-474-01) / 1 mL in 1 VIAL |
| VASOPRESSIN | vasopressin | SOLUTION;INTRAVENOUS | 216963 | ANDA | Gland Pharma Limited | 68083-520 | 68083-520-10 | 10 VIAL in 1 CARTON (68083-520-10) / 1 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 20UNITS/ML (20UNITS/ML) | ||||
| Approval Date: | Feb 9, 2024 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 40UNITS/100ML (0.4UNITS/ML) | ||||
| Approval Date: | Aug 22, 2025 | TE: | AP | RLD: | No | ||||
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