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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N212593-002 | VASOPRESSIN | 200UNITS/10ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212593-002 | VASOPRESSIN | 200UNITS/10ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N212593-002 | VASOPRESSIN | 200UNITS/10ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N212593-002 | VASOPRESSIN | 200UNITS/10ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N212593-002 | VASOPRESSIN | 200UNITS/10ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212593-002 | VASOPRESSIN | 200UNITS/10ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212593-002 | VASOPRESSIN | 200UNITS/10ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-09 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212593-002 | VASOPRESSIN | 200UNITS/10ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-09 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N212593-002 | VASOPRESSIN | 200UNITS/10ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-09 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N212593-002 | VASOPRESSIN | 200UNITS/10ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-09 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N212593-002 | VASOPRESSIN | 200UNITS/10ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-09 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N212593-002 | VASOPRESSIN | 200UNITS/10ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-09 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N212593-002 | VASOPRESSIN | 200UNITS/10ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-09 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N212593-002 | VASOPRESSIN | 200UNITS/10ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-09 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N212593-001 | VASOPRESSIN | 20UNITS/ML (20UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-08-03 | 87673890dc5c… | |
| 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… |
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 |