Details for New Drug Application (NDA): 213206
NDA 213206 describes VASOPRESSIN, which is a drug marketed by Am Regent, Amneal, Amphastar Pharms Inc, Cipla, Dr Reddys, Eagle Pharms, Eugia Pharma, Fresenius Kabi Usa, Gland, Sandoz, Baxter Hlthcare Corp, and Long Grove Pharms, and is included in thirteen NDAs. It is available from twelve suppliers. There is one patent protecting this drug. Additional details are available on the VASOPRESSIN profile page.
The generic ingredient in VASOPRESSIN is vasopressin. There is one drug master file entry for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the vasopressin profile page.
The generic ingredient in VASOPRESSIN is vasopressin. There is one drug master file entry for this compound. Sixteen 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 |
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 | ||||
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