Application 076768
- Type
- ANDA
- Sponsor
- CIPLA
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 |
|---|---|---|---|---|---|---|---|
| A076768-001 | ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2008-08-04 | |
| A076768-002 | ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2008-08-04 | |
| A076768-003 | ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 35MG BASE | TABLET / ORAL | AB | 2008-08-04 | |
| A076768-004 | ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2008-08-04 | |
| A076768-005 | ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET / ORAL | AB | 2008-08-04 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076768-001 | AB |
| A076768-002 | AB |
| A076768-003 | AB |
| A076768-004 | AB |
| A076768-005 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076768-001 | ALENDRONATE SODIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2008-08-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076768-002 | ALENDRONATE SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2008-08-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076768-003 | ALENDRONATE SODIUM | EQ 35MG BASE | TABLET / ORAL | AB | 2008-08-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076768-004 | ALENDRONATE SODIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2008-08-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076768-005 | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET / ORAL | AB | 2008-08-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076768-001 | ALENDRONATE SODIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2008-08-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076768-002 | ALENDRONATE SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2008-08-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076768-003 | ALENDRONATE SODIUM | EQ 35MG BASE | TABLET / ORAL | AB | 2008-08-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076768-004 | ALENDRONATE SODIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2008-08-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076768-005 | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET / ORAL | AB | 2008-08-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076768-001 | ALENDRONATE SODIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2008-08-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076768-002 | ALENDRONATE SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2008-08-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076768-003 | ALENDRONATE SODIUM | EQ 35MG BASE | TABLET / ORAL | AB | 2008-08-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076768-004 | ALENDRONATE SODIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2008-08-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076768-005 | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET / ORAL | AB | 2008-08-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076768-001 | ALENDRONATE SODIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2008-08-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076768-002 | ALENDRONATE SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2008-08-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076768-003 | ALENDRONATE SODIUM | EQ 35MG BASE | TABLET / ORAL | AB | 2008-08-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076768-004 | ALENDRONATE SODIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2008-08-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076768-005 | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET / ORAL | AB | 2008-08-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076768-001 | ALENDRONATE SODIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2008-08-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076768-002 | ALENDRONATE SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2008-08-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076768-003 | ALENDRONATE SODIUM | EQ 35MG BASE | TABLET / ORAL | AB | 2008-08-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076768-004 | ALENDRONATE SODIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2008-08-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076768-005 | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET / ORAL | AB | 2008-08-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076768-001 | ALENDRONATE SODIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2008-08-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076768-002 | ALENDRONATE SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2008-08-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076768-003 | ALENDRONATE SODIUM | EQ 35MG BASE | TABLET / ORAL | AB | 2008-08-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076768-004 | ALENDRONATE SODIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2008-08-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076768-005 | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET / ORAL | AB | 2008-08-04 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076768-001 | ALENDRONATE SODIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2008-08-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076768-002 | ALENDRONATE SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2008-08-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076768-003 | ALENDRONATE SODIUM | EQ 35MG BASE | TABLET / ORAL | AB | 2008-08-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076768-004 | ALENDRONATE SODIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2008-08-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076768-005 | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET / ORAL | AB | 2008-08-04 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076768-001 | ALENDRONATE SODIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2008-08-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076768-002 | ALENDRONATE SODIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2008-08-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076768-003 | ALENDRONATE SODIUM | EQ 35MG BASE | TABLET / ORAL | AB | 2008-08-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076768-004 | ALENDRONATE SODIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2008-08-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076768-005 | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET / ORAL | AB | 2008-08-04 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076768-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076768-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076768-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076768-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076768-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076768-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076768-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076768-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076768-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076768-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076768-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076768-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076768-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076768-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076768-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076768-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076768-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076768-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076768-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076768-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076768-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076768-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076768-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076768-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076768-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076768-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076768-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076768-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076768-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076768-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076768-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076768-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076768-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076768-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076768-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076768-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076768-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076768-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076768-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076768-005 | AB | 1 | 5bbf6a4d5a75… |
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 | REMEDYREPACK INC. | c7e470d6-508e-466e-a78d-060bbbc9745c | 2026-07-03 | Warnings, Adverse reactions | 076768 ANDA076768 |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | NuCare Pharmaceuticals,Inc. | 54d6543d-4239-58b1-e054-00144ff88e88 | 2026-06-23 | Warnings, Adverse reactions | 076768 ANDA076768 68071-3340 |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | REMEDYREPACK INC. | c4358ba7-1bf8-4b0a-9407-5ac279d04555 | 2026-06-22 | Warnings, Adverse reactions | 076768 ANDA076768 70518-0033 |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | Cipla USA Inc. | e2fac28d-ad91-4cdc-a003-9fdeac073f76 | 2026-03-25 | Warnings, Adverse reactions | 076768 ANDA076768 69097-224 69097-223 |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | Preferred Pharmaceuticals Inc. | 83e3ba94-d882-4b5c-87cb-af1eb0997efc | 2026-02-16 | Warnings, Adverse reactions | 076768 ANDA076768 68788-7130 |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | A-S Medication Solutions | fe1dd324-eb02-4a73-97f5-9b77a7df10a7 | 2025-12-05 | Warnings, Adverse reactions | 076768 ANDA076768 50090-4692 |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | NuCare Pharmaceuticals, Inc. | 2baf8516-4148-9007-e063-6394a90a8094 | 2025-01-14 | Warnings, Adverse reactions | 076768 ANDA076768 |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EXELAN PHARMACEUTICALS INC. | 91a0f73a-d8cd-4197-b431-40707a2150b9 | 2023-08-25 | Warnings, Adverse reactions | 076768 ANDA076768 76282-682 76282-681 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 21695-901 | Alendronate Sodium | alendronate sodium | Rebel Distributors Corp | ANDA | Current |
| 21695-902 | Alendronate Sodium | alendronate sodium | Rebel Distributors Corp | ANDA | Current |
| 50090-4076 | ALENDRONATE SODIUM | Alendronate sodium | A-S Medication Solutions | ANDA | Current |
| 50090-4076 | ALENDRONATE SODIUM | Alendronate sodium | A-S Medication Solutions | ANDA | Current |
| 50090-4692 | ALENDRONATE SODIUM | Alendronate sodium | A-S Medication Solutions | ANDA | Current |
| 50090-4692 | ALENDRONATE SODIUM | Alendronate sodium | A-S Medication Solutions | ANDA | Current |
| 50090-4692 | ALENDRONATE SODIUM | Alendronate sodium | A-S Medication Solutions | ANDA | Current |
| 50090-4692 | ALENDRONATE SODIUM | Alendronate sodium | A-S Medication Solutions | ANDA | Current |
| 61919-689 | ALENDRONATE SODIUM | ALENDRONATE SODIUM | DIRECT RX | ANDA | Current |
| 61919-729 | Alendronate Sodium | Alendronate Sodium | Direct_Rx | ANDA | Current |
| 68071-3171 | ALENDRONATE SODIUM | Alendronate sodium | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3171 | ALENDRONATE SODIUM | Alendronate sodium | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3171 | ALENDRONATE SODIUM | Alendronate sodium | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3340 | ALENDRONATE SODIUM | Alendronate sodium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3340 | ALENDRONATE SODIUM | Alendronate sodium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3340 | ALENDRONATE SODIUM | Alendronate sodium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7130 | ALENDRONATE SODIUM | Alendronate sodium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7130 | ALENDRONATE SODIUM | Alendronate sodium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7130 | ALENDRONATE SODIUM | Alendronate sodium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7130 | ALENDRONATE SODIUM | Alendronate sodium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 69097-223 | ALENDRONATE SODIUM | Alendronate sodium | Cipla USA Inc. | ANDA | Current |
| 69097-223 | ALENDRONATE SODIUM | Alendronate sodium | Cipla USA Inc. | ANDA | Current |
| 69097-223 | ALENDRONATE SODIUM | Alendronate sodium | Cipla USA Inc. | ANDA | Current |
| 69097-224 | ALENDRONATE SODIUM | Alendronate sodium | Cipla USA Inc. | ANDA | Current |
| 69097-224 | ALENDRONATE SODIUM | Alendronate sodium | Cipla USA Inc. | ANDA | Current |
| 69097-224 | ALENDRONATE SODIUM | Alendronate sodium | Cipla USA Inc. | ANDA | Current |
| 70518-0033 | ALENDRONATE SODIUM | Alendronate sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0033 | ALENDRONATE SODIUM | Alendronate sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0033 | ALENDRONATE SODIUM | Alendronate sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0033 | ALENDRONATE SODIUM | Alendronate sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0033 | ALENDRONATE SODIUM | Alendronate sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0033 | ALENDRONATE SODIUM | Alendronate sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0033 | ALENDRONATE SODIUM | Alendronate sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0033 | ALENDRONATE SODIUM | Alendronate sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0033 | ALENDRONATE SODIUM | Alendronate sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0033 | ALENDRONATE SODIUM | Alendronate sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0033 | ALENDRONATE SODIUM | Alendronate sodium | REMEDYREPACK INC. | ANDA | Current |
| 76282-681 | ALENDRONATE SODIUM | Alendronate sodium | Exelan Pharmaceuticals Inc. | ANDA | Current |
| 76282-682 | ALENDRONATE SODIUM | Alendronate sodium | Exelan Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44320 | ORIG | 2008-09-19 |