Details for New Drug Application (NDA): 216963
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NDA 216963 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 Pharma Ltd, Baxter Hlthcare Corp, and Long Grove Pharms, and is included in eleven 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 216963
| Tradename: | VASOPRESSIN |
| Applicant: | Gland Pharma Ltd |
| 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 | Gland Pharma Limited | 68083-520 | 68083-520-10 | 10 VIAL in 1 CARTON (68083-520-10) / 1 mL in 1 VIAL |
| VASOPRESSIN | vasopressin | SOLUTION;INTRAVENOUS | 216963 | ANDA | Gland Pharma Limited | 68083-520 | 68083-520-25 | 25 VIAL in 1 CARTON (68083-520-25) / 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 | ||||
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