Application 075710
- Type
- ANDA
- Sponsor
- IMPAX LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ALENDRONATE SODIUM | ALENDRONATE SODIUM | TABLET;ORAL | EQ 5MG BASE | No | No |
| 002 | ALENDRONATE SODIUM | ALENDRONATE SODIUM | TABLET;ORAL | EQ 10MG BASE | No | No |
| 003 | ALENDRONATE SODIUM | ALENDRONATE SODIUM | TABLET;ORAL | EQ 35MG BASE | No | No |
| 004 | ALENDRONATE SODIUM | ALENDRONATE SODIUM | TABLET;ORAL | EQ 40MG BASE | No | No |
| 005 | ALENDRONATE SODIUM | ALENDRONATE SODIUM | TABLET;ORAL | EQ 70MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075710-001 | ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 5MG BASE | TABLET / ORAL | 2008-02-06 | ||
| A075710-002 | ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 10MG BASE | TABLET / ORAL | 2008-02-06 | ||
| A075710-003 | ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 35MG BASE | TABLET / ORAL | 2008-02-06 | ||
| A075710-004 | ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 40MG BASE | TABLET / ORAL | 2008-02-06 | ||
| A075710-005 | ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET / ORAL | 2008-02-06 |
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 | A075710-001 | ALENDRONATE SODIUM | EQ 5MG BASE | TABLET / ORAL | 2008-02-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075710-002 | ALENDRONATE SODIUM | EQ 10MG BASE | TABLET / ORAL | 2008-02-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075710-003 | ALENDRONATE SODIUM | EQ 35MG BASE | TABLET / ORAL | 2008-02-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075710-004 | ALENDRONATE SODIUM | EQ 40MG BASE | TABLET / ORAL | 2008-02-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075710-005 | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET / ORAL | 2008-02-06 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075710-001 | ALENDRONATE SODIUM | EQ 5MG BASE | TABLET / ORAL | 2008-02-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075710-002 | ALENDRONATE SODIUM | EQ 10MG BASE | TABLET / ORAL | 2008-02-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075710-003 | ALENDRONATE SODIUM | EQ 35MG BASE | TABLET / ORAL | 2008-02-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075710-004 | ALENDRONATE SODIUM | EQ 40MG BASE | TABLET / ORAL | 2008-02-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075710-005 | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET / ORAL | 2008-02-06 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075710-001 | ALENDRONATE SODIUM | EQ 5MG BASE | TABLET / ORAL | 2008-02-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075710-002 | ALENDRONATE SODIUM | EQ 10MG BASE | TABLET / ORAL | 2008-02-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075710-003 | ALENDRONATE SODIUM | EQ 35MG BASE | TABLET / ORAL | 2008-02-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075710-004 | ALENDRONATE SODIUM | EQ 40MG BASE | TABLET / ORAL | 2008-02-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075710-005 | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET / ORAL | 2008-02-06 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075710-001 | ALENDRONATE SODIUM | EQ 5MG BASE | TABLET / ORAL | 2008-02-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075710-002 | ALENDRONATE SODIUM | EQ 10MG BASE | TABLET / ORAL | 2008-02-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075710-003 | ALENDRONATE SODIUM | EQ 35MG BASE | TABLET / ORAL | 2008-02-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075710-004 | ALENDRONATE SODIUM | EQ 40MG BASE | TABLET / ORAL | 2008-02-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075710-005 | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET / ORAL | 2008-02-06 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075710-001 | ALENDRONATE SODIUM | EQ 5MG BASE | TABLET / ORAL | 2008-02-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075710-002 | ALENDRONATE SODIUM | EQ 10MG BASE | TABLET / ORAL | 2008-02-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075710-003 | ALENDRONATE SODIUM | EQ 35MG BASE | TABLET / ORAL | 2008-02-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075710-004 | ALENDRONATE SODIUM | EQ 40MG BASE | TABLET / ORAL | 2008-02-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075710-005 | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET / ORAL | 2008-02-06 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075710-001 | ALENDRONATE SODIUM | EQ 5MG BASE | TABLET / ORAL | 2008-02-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075710-002 | ALENDRONATE SODIUM | EQ 10MG BASE | TABLET / ORAL | 2008-02-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075710-003 | ALENDRONATE SODIUM | EQ 35MG BASE | TABLET / ORAL | 2008-02-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075710-004 | ALENDRONATE SODIUM | EQ 40MG BASE | TABLET / ORAL | 2008-02-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075710-005 | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET / ORAL | 2008-02-06 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075710-001 | ALENDRONATE SODIUM | EQ 5MG BASE | TABLET / ORAL | 2008-02-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075710-002 | ALENDRONATE SODIUM | EQ 10MG BASE | TABLET / ORAL | 2008-02-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075710-003 | ALENDRONATE SODIUM | EQ 35MG BASE | TABLET / ORAL | 2008-02-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075710-004 | ALENDRONATE SODIUM | EQ 40MG BASE | TABLET / ORAL | 2008-02-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075710-005 | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET / ORAL | 2008-02-06 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075710-001 | ALENDRONATE SODIUM | EQ 5MG BASE | TABLET / ORAL | 2008-02-06 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075710-002 | ALENDRONATE SODIUM | EQ 10MG BASE | TABLET / ORAL | 2008-02-06 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075710-003 | ALENDRONATE SODIUM | EQ 35MG BASE | TABLET / ORAL | 2008-02-06 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075710-004 | ALENDRONATE SODIUM | EQ 40MG BASE | TABLET / ORAL | 2008-02-06 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075710-005 | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET / ORAL | 2008-02-06 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A075710-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A075710-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A075710-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A075710-004 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A075710-005 | AB | 1 | 74a2ff9319b5… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075710-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075710-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075710-003 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075710-004 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075710-005 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A075710-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A075710-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A075710-003 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A075710-004 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A075710-005 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A075710-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A075710-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A075710-003 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A075710-004 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A075710-005 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A075710-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A075710-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A075710-003 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A075710-004 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A075710-005 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A075710-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A075710-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A075710-003 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A075710-004 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A075710-005 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A075710-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A075710-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A075710-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A075710-004 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A075710-005 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A075710-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A075710-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A075710-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A075710-004 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A075710-005 | AB | 1 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| Alendronate Sodium | ALENDRONATE SODIUM | Amneal Pharmaceuticals of New York LLC | c23fb7fe-c6b9-4f77-bde7-992222b589d3 | 2021-02-02 | Warnings, Adverse reactions | 075710 ANDA075710 0115-1680 0115-1676 0115-1681 0115-1679 0115-1678 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0115-1676 | Alendronate Sodium | Alendronate Sodium | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1676 | Alendronate Sodium | Alendronate Sodium | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1676 | Alendronate Sodium | Alendronate Sodium | Impax Generics | ANDA | Current |
| 0115-1676 | Alendronate Sodium | Alendronate Sodium | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1678 | Alendronate Sodium | Alendronate Sodium | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1678 | Alendronate Sodium | Alendronate Sodium | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1678 | Alendronate Sodium | Alendronate Sodium | Impax Generics | ANDA | Current |
| 0115-1678 | Alendronate Sodium | Alendronate Sodium | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1679 | Alendronate Sodium | Alendronate Sodium | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1679 | Alendronate Sodium | Alendronate Sodium | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1679 | Alendronate Sodium | Alendronate Sodium | Impax Generics | ANDA | Current |
| 0115-1679 | Alendronate Sodium | Alendronate Sodium | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1680 | Alendronate Sodium | Alendronate Sodium | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1680 | Alendronate Sodium | Alendronate Sodium | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1680 | Alendronate Sodium | Alendronate Sodium | Impax Generics | ANDA | Current |
| 0115-1680 | Alendronate Sodium | Alendronate Sodium | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1681 | Alendronate Sodium | Alendronate Sodium | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1681 | Alendronate Sodium | Alendronate Sodium | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1681 | Alendronate Sodium | Alendronate Sodium | Impax Generics | ANDA | Current |
| 0115-1681 | Alendronate Sodium | Alendronate Sodium | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 33261-554 | Alendronate Sodium | Alendronate Sodium | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-820 | Alendronate Sodium | Alendronate Sodium | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-993 | Alendronate Sodium | Alendronate Sodium | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 63187-175 | Alendronate Sodium | Alendronate Sodium | Proficient Rx LP | ANDA | Current |
| 66116-428 | Alendronate Sodium | Alendronate Sodium | MedVantx, Inc. | ANDA | Current |
| 68788-7393 | Alendronate Sodium | Alendronate Sodium | Preferred Pharmaceuticals Inc. | ANDA | Current |