Application 212593
- Type
- NDA
- Sponsor
- American Regent, Inc.
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | VASOPRESSIN | VASOPRESSIN | SOLUTION;INTRAVENOUS | 20UNITS/ML (20UNITS/ML) | No | No |
| 002 | VASOPRESSIN | VASOPRESSIN | SOLUTION;INTRAVENOUS | 200UNITS/10ML (20UNITS/ML) | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0517-1020 | Vasopressin | Vasopressin | American Regent, Inc. | NDA | Current |
| 0517-1020 | Vasopressin | Vasopressin | American Regent, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 67519 | ORIG | 2021-05-17 |
| 64197 | ORIG | 2020-08-04 |
| 61736 | ORIG | 2020-01-29 |