Details for New Drug Application (NDA): 213206
✉ Email this page to a colleague
NDA 213206 describes VASOPRESSIN, which is a drug marketed by Am Regent, Amneal, Amphastar Pharms Inc, Cipla, Eagle Pharms, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, and Baxter Hlthcare Corp, and is included in nine NDAs. It is available from nine suppliers. Additional details are available on the VASOPRESSIN profile page.
The generic ingredient in VASOPRESSIN 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 VASOPRESSIN 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 213206
| Tradename: | VASOPRESSIN |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | vasopressin |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 213206
| Physiological Effect | Decreased Diuresis Vasoconstriction |
Suppliers and Packaging for NDA: 213206
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VASOPRESSIN | vasopressin | SOLUTION;INTRAVENOUS | 213206 | ANDA | Fresenius Kabi USA, LLC | 63323-930 | 63323-930-01 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-930-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-930-00) |
| VASOPRESSIN | vasopressin | SOLUTION;INTRAVENOUS | 213206 | ANDA | Fresenius Kabi USA, LLC | 65219-039 | 65219-039-01 | 25 VIAL, SINGLE-DOSE in 1 TRAY (65219-039-01) / 1 mL in 1 VIAL, SINGLE-DOSE (65219-039-00) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 20UNITS/ML (20UNITS/ML) | ||||
| Approval Date: | May 26, 2023 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
