Application 075147
- Type
- ANDA
- Sponsor
- ANI PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | TABLET;ORAL | 20MG | No | No |
| 002 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | TABLET;ORAL | 10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075147-001 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 20MG | TABLET / ORAL | AB | 1998-11-27 | |
| A075147-002 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 10MG | TABLET / ORAL | AB | 2026-03-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075147-001 | AB |
| A075147-002 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2023-05-13 08:27 UTC | 2023-05 | A075147-001 | ISOSORBIDE MONONITRATE | 20MG | TABLET / ORAL | 1998-11-27 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A075147-001 | ISOSORBIDE MONONITRATE | 20MG | TABLET / ORAL | 1998-11-27 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A075147-001 | ISOSORBIDE MONONITRATE | 20MG | TABLET / ORAL | 1998-11-27 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A075147-001 | ISOSORBIDE MONONITRATE | 20MG | TABLET / ORAL | 1998-11-27 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A075147-001 | ISOSORBIDE MONONITRATE | 20MG | TABLET / ORAL | 1998-11-27 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A075147-001 | ISOSORBIDE MONONITRATE | 20MG | TABLET / ORAL | 1998-11-27 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A075147-001 | ISOSORBIDE MONONITRATE | 20MG | TABLET / ORAL | AB | 1998-11-27 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A075147-002 | ISOSORBIDE MONONITRATE | 10MG | TABLET / ORAL | AB | 2026-03-27 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A075147-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A075147-002 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A075147-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075147-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A075147-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075147-002 | AB | 1 | caaa826d4ba7… |
| 2019-12-13 00:20 UTC | 2019-12 | A075147-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A075147-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A075147-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A075147-001 | AB | 1 | ea99ee380514… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A075147-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A075147-002 | AB | 1 | 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 |
|---|---|---|---|---|---|---|
| Isosorbide Mononitrate | ISOSORBIDE MONONITRATE | Coupler LLC | 55f240e1-3056-38cc-e063-6294a90a814e | 2026-07-06 | Warnings, Adverse reactions | 075147 ANDA075147 |
| Isosorbide Mononitrate | ISOSORBIDE MONONITRATE | ANI Pharmaceuticals, Inc. | 06839534-85b8-42aa-b0e3-079ed236be44 | 2026-03-27 | Warnings, Adverse reactions | 075147 ANDA075147 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.