Application 212593
- Type
- NDA
- Sponsor
- American Regent, Inc.
Application Products#
| 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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N212593-001 | VASOPRESSIN | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | |
| N212593-002 | VASOPRESSIN | VASOPRESSIN | 200UNITS/10ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-09 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2021-03-12 10:30 UTC | 2021-03 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | c0c555d07b60… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N212593-002 | VASOPRESSIN | 200UNITS/10ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-09 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | N212593-002 | VASOPRESSIN | 200UNITS/10ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-09 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | N212593-002 | VASOPRESSIN | 200UNITS/10ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-09 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N212593-002 | VASOPRESSIN | 200UNITS/10ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-09 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N212593-002 | VASOPRESSIN | 200UNITS/10ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-09 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N212593-002 | VASOPRESSIN | 200UNITS/10ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-09 | a50c72e98297… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| VASOPRESSIN | VASOPRESSIN | HF Acquisition Co LLC, DBA HealthFirst | 5232a8bc-d7ae-48a5-e063-6294a90a76ca | 2026-07-21 | Warnings, Adverse reactions | 212593 NDA212593 |
| VASOPRESSIN | VASOPRESSIN | HF Acquisition Co LLC, DBA HealthFirst | 52324969-4536-2b7c-e063-6394a90a9b4d | 2026-07-10 | Warnings, Adverse reactions | 212593 NDA212593 |
| Vasopressin | VASOPRESSIN | Civica, Inc. | cce1a220-3178-49ec-b046-f0cb134cf051 | 2025-03-01 | Warnings, Adverse reactions | 212593 NDA212593 |
| Vasopressin | VASOPRESSIN | American Regent, Inc. | 0ab267f4-9ec9-44fd-8521-f975074667d9 | 2024-10-31 | Warnings, Adverse reactions | 212593 NDA212593 0517-1020 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.