Application 075571
- Type
- ANDA
- Sponsor
- HOSPIRA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ENALAPRILAT | ENALAPRILAT | INJECTABLE;INJECTION | 1.25MG/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075571-001 | ENALAPRILAT | ENALAPRILAT | 1.25MG/ML | INJECTABLE / INJECTION | 2000-08-22 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | A075571-001 | ENALAPRILAT | 1.25MG/ML | INJECTABLE / INJECTION | 2000-08-22 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A075571-001 | ENALAPRILAT | 1.25MG/ML | INJECTABLE / INJECTION | 2000-08-22 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A075571-001 | ENALAPRILAT | 1.25MG/ML | INJECTABLE / INJECTION | 2000-08-22 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A075571-001 | ENALAPRILAT | 1.25MG/ML | INJECTABLE / INJECTION | 2000-08-22 | 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 |
|---|---|---|---|---|---|---|
| Enalaprilat | ENALAPRILAT | Dr. Reddys Laboratories Inc | 5d398da1-020c-ccb1-a775-ce8e0b29d621 | 2024-06-07 | Boxed warning, Warnings, Adverse reactions | Enalaprilat ENALAPRILAT |
| ENALAPRILAT | ENALAPRILAT | HF Acquisition Co LLC, DBA HealthFirst | 9d88f915-13dd-5463-e053-2a95a90a09bf | 2024-02-22 | Boxed warning, Warnings, Adverse reactions | ENALAPRILAT ENALAPRILAT |
| Enalaprilat | ENALAPRILAT | Hikma Pharmaceuticals USA Inc. | eabae489-e254-4987-ab90-7cda20a6f856 | 2024-01-04 | Boxed warning, Warnings, Adverse reactions | Enalaprilat ENALAPRILAT |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.