Application 065489
- Type
- ANDA
- Sponsor
- AUROBINDO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CLARITHROMYCIN | CLARITHROMYCIN | TABLET;ORAL | 250MG | No | Yes |
| 002 | CLARITHROMYCIN | CLARITHROMYCIN | TABLET;ORAL | 500MG | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065489-001 | CLARITHROMYCIN | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 |
| A065489-002 | CLARITHROMYCIN | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A065489-001 | AB |
| A065489-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A065489-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A065489-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065489-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065489-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A065489-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A065489-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065489-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065489-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065489-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065489-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065489-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065489-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065489-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065489-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065489-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065489-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065489-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065489-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065489-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A065489-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065489-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065489-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065489-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065489-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065489-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065489-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A065489-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A065489-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065489-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065489-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A065489-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A065489-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A065489-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A065489-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A065489-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A065489-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A065489-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A065489-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A065489-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A065489-002 | AB | 1 | 782e0a99824c… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Clarithromycin | CLARITHROMYCIN | Sportpharm LLC | d836ae7e-fdbf-4dcb-a90d-ede1dcbc3e67 | 2026-06-24 | Warnings, Adverse reactions | 065489 ANDA065489 |
| Clarithromycin | CLARITHROMYCIN | REMEDYREPACK INC. | 9d5848f0-e9f0-4112-a7ca-bcc8ea2e69c6 | 2026-06-24 | Warnings, Adverse reactions | 065489 ANDA065489 70518-0204 |
| Clarithromycin | CLARITHROMYCIN | Proficient Rx LP | 88c7ded8-333c-408d-b693-a72881710f59 | 2026-04-01 | Warnings, Adverse reactions | 065489 ANDA065489 |
| Clarithromycin | CLARITHROMYCIN | Preferred Pharmaceuticals Inc. | 81c0c69e-b1ae-42f3-9e85-09b8daa75d8d | 2026-03-30 | Warnings, Adverse reactions | 065489 ANDA065489 |
| Clarithromycin | CLARITHROMYCIN | Major Pharmaceuticals | d0a66646-6774-4fc6-9b26-a98c3a5df274 | 2026-03-26 | Warnings, Adverse reactions | 065489 ANDA065489 0904-6872 |
| Clarithromycin | CLARITHROMYCIN | American Health Packaging | fa69ea92-0b41-43fb-918f-ed80e0dedf04 | 2026-03-04 | Warnings, Adverse reactions | 065489 ANDA065489 |
| Clarithromycin | CLARITHROMYCIN | AvPAK | 1920f943-bbf1-cfd9-7475-96a35680a9e0 | 2026-02-11 | Warnings, Adverse reactions | 065489 ANDA065489 50268-178 50268-179 |
| Clarithromycin | CLARITHROMYCIN | Northwind Health Company, LLC | 471f638a-9dd1-09d3-e063-6294a90a2d4f | 2026-01-08 | Warnings, Adverse reactions | 065489 ANDA065489 |
| Clarithromycin | CLARITHROMYCIN | Direct_Rx | 3ba1da51-ba5b-323f-e063-6294a90a0333 | 2025-09-08 | Warnings, Adverse reactions | 065489 ANDA065489 |
| Clarithromycin | CLARITHROMYCIN | PD-Rx Pharmaceuticals, Inc. | ba216276-b0bd-420a-9e0d-090bdfcc2460 | 2025-08-05 | Warnings, Adverse reactions | 065489 ANDA065489 43063-823 |
| Clarithromycin | CLARITHROMYCIN | A-S Medication Solutions | 25debd85-0840-4f8d-9898-027772061dd2 | 2025-06-09 | Warnings, Adverse reactions | 065489 ANDA065489 50090-1830 |
| Clarithromycin | CLARITHROMYCIN | NuCare Pharmaceuticals,Inc. | 9143b79c-4c79-43ac-e053-2995a90ad708 | 2025-02-04 | Warnings, Adverse reactions | 065489 ANDA065489 68071-5045 |
| Clarithromycin | CLARITHROMYCIN | Bryant Ranch Prepack | 0c7d8391-50ef-4827-abe6-e0fc0c2f1636 | 2024-01-16 | Warnings, Adverse reactions | 065489 ANDA065489 71335-0017 |
| Clarithromycin | CLARITHROMYCIN | Rising Pharma Holdings, Inc. | 0c4db97f-f4c9-4cac-9f12-9db1d967ebeb | 2024-01-05 | Warnings, Adverse reactions | 065489 ANDA065489 57237-044 57237-045 |
| Clarithromycin | CLARITHROMYCIN | Aurobindo Pharma Limited | 9aaffb41-408c-4372-8fd5-1d649450c0e9 | 2023-10-10 | Warnings, Adverse reactions | 065489 ANDA065489 65862-226 65862-225 |
| Clarithromycin | CLARITHROMYCIN | A-S Medication Solutions | 1d6f5a9d-51b2-4e0d-b573-ccf08fe6ea23 | 2023-07-31 | Warnings, Adverse reactions | 065489 ANDA065489 |
| Clarithromycin | CLARITHROMYCIN | Proficient Rx LP | b1bdf526-4f16-4130-b614-4cb678f060d7 | 2021-01-01 | Warnings, Adverse reactions | 065489 ANDA065489 63187-625 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0904-6872 | Clarithromycin | Clarithromycin | Major Pharmaceuticals | ANDA | Current |
| 0904-6872 | Clarithromycin | Clarithromycin | Major Pharmaceuticals | ANDA | Current |
| 43063-823 | Clarithromycin | Clarithromycin | PD-Rx Pharmaceuticals, In | ANDA | Current |
| 43063-823 | Clarithromycin | Clarithromycin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-823 | Clarithromycin | Clarithromycin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-823 | Clarithromycin | Clarithromycin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-823 | Clarithromycin | Clarithromycin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-823 | Clarithromycin | Clarithromycin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 50090-1830 | Clarithromycin | Clarithromycin | A-S Medication Solutions | ANDA | Current |
| 50090-1830 | Clarithromycin | Clarithromycin | A-S Medication Solutions | ANDA | Current |
| 50090-1830 | Clarithromycin | Clarithromycin | A-S Medication Solutions | ANDA | Current |
| 50268-178 | Clarithromycin | Clarithromycin | AvPAK | ANDA | Current |
| 50268-178 | Clarithromycin | Clarithromycin | AvPAK | ANDA | Current |
| 50268-178 | Clarithromycin | Clarithromycin | AvPAK | ANDA | Current |
| 50268-179 | Clarithromycin | Clarithromycin | AvPAK | ANDA | Current |
| 50268-179 | Clarithromycin | Clarithromycin | AvPAK | ANDA | Current |
| 50268-179 | Clarithromycin | Clarithromycin | AvPAK | ANDA | Current |
| 57237-044 | Clarithromycin | Clarithromycin | Rising Health, LLC | ANDA | Current |
| 57237-044 | Clarithromycin | Clarithromycin | Rising Health, LLC | ANDA | Current |
| 57237-044 | Clarithromycin | Clarithromycin | Rising Health, LLC | ANDA | Current |
| 57237-044 | Clarithromycin | Clarithromycin | Rising Health, LLC | ANDA | Current |
| 57237-044 | Clarithromycin | Clarithromycin | Rising Health, LLC | ANDA | Current |
| 57237-045 | Clarithromycin | Clarithromycin | Rising Health, LLC | ANDA | Current |
| 57237-045 | Clarithromycin | Clarithromycin | Rising Health, LLC | ANDA | Current |
| 57237-045 | Clarithromycin | Clarithromycin | Rising Health, LLC | ANDA | Current |
| 57237-045 | Clarithromycin | Clarithromycin | Rising Health, LLC | ANDA | Current |
| 57237-045 | Clarithromycin | Clarithromycin | Rising Health, LLC | ANDA | Current |
| 63187-625 | Clarithromycin | Clarithromycin | Proficient Rx LP | ANDA | Current |
| 63187-625 | Clarithromycin | Clarithromycin | Proficient Rx LP | ANDA | Current |
| 65862-225 | Clarithromycin | Clarithromycin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-225 | Clarithromycin | Clarithromycin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-225 | Clarithromycin | Clarithromycin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-225 | Clarithromycin | Clarithromycin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-225 | Clarithromycin | Clarithromycin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-226 | Clarithromycin | Clarithromycin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-226 | Clarithromycin | Clarithromycin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-226 | Clarithromycin | Clarithromycin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-226 | Clarithromycin | Clarithromycin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-226 | Clarithromycin | Clarithromycin | Aurobindo Pharma Limited | ANDA | Current |
| 67296-1632 | Clarithromycin | Clarithromycin | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1632 | Clarithromycin | Clarithromycin | RedPharm Drug, Inc. | ANDA | Current |
| 68071-1899 | Clarithromycin | Clarithromycin | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-5045 | Clarithromycin | Clarithromycin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5045 | Clarithromycin | Clarithromycin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5045 | Clarithromycin | Clarithromycin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5045 | Clarithromycin | Clarithromycin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-6936 | Clarithromycin | Clarithromycin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6936 | Clarithromycin | Clarithromycin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-0204 | Clarithromycin | Clarithromycin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0204 | Clarithromycin | Clarithromycin | REMEDYREPACK INC. | ANDA | Current |
| 71335-0017 | Clarithromycin | Clarithromycin | Bryant Ranch Prepack | ANDA | Current |
| 71335-0017 | Clarithromycin | Clarithromycin | Bryant Ranch Prepack | ANDA | Current |
| 71335-0017 | Clarithromycin | Clarithromycin | Bryant Ranch Prepack | ANDA | Current |
| 71335-0017 | Clarithromycin | Clarithromycin | Bryant Ranch Prepack | ANDA | Current |