Application 076945
- Type
- ANDA
- Sponsor
- TEVA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE | FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 10MG;12.5MG | No | No |
| 002 | FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE | FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 20MG;12.5MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076945-001 | FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE | FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET / ORAL | 2006-07-05 | ||
| A076945-002 | FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE | FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET / ORAL | 2006-07-05 |
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 | A076945-001 | FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET / ORAL | 2006-07-05 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A076945-002 | FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET / ORAL | 2006-07-05 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A076945-001 | FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET / ORAL | 2006-07-05 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A076945-002 | FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET / ORAL | 2006-07-05 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A076945-001 | FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET / ORAL | 2006-07-05 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A076945-002 | FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET / ORAL | 2006-07-05 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A076945-001 | FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET / ORAL | 2006-07-05 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A076945-002 | FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET / ORAL | 2006-07-05 | 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 |
|---|---|---|---|---|---|---|
| Fosinopril Sodium and Hydrochlorothiazide | FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE | Aurobindo Pharma Limited | 35019655-9a30-4305-a262-936ad0e73071 | 2024-04-28 | Boxed warning, Warnings, Adverse reactions | Fosinopril Sodium and Hydrochlorothiazide |
| Fosinopril Sodium and Hydrochlorothiazide | FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE | CIPLA USA INC. | 4e1ed7da-029e-48d6-a5e4-fc7ac11192fb | 2020-11-03 | Boxed warning, Warnings, Adverse reactions | Fosinopril Sodium and Hydrochlorothiazide |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44328 | ORIG | 2006-07-17 |