Application 211147
- Type
- ANDA
- Sponsor
- ZYDUS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AZITHROMYCIN | AZITHROMYCIN | FOR SUSPENSION;ORAL | EQ 100MG BASE/5ML | No | No |
| 002 | AZITHROMYCIN | AZITHROMYCIN | FOR SUSPENSION;ORAL | EQ 200MG BASE/5ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211147-001 | AZITHROMYCIN | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | |
| A211147-002 | AZITHROMYCIN | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A211147-001 | AB |
| A211147-002 | 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 | A211147-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211147-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211147-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211147-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211147-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211147-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211147-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211147-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211147-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211147-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211147-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211147-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211147-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211147-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211147-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211147-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211147-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211147-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A211147-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A211147-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211147-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211147-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211147-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211147-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211147-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211147-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A211147-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A211147-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211147-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211147-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A211147-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A211147-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A211147-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A211147-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A211147-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A211147-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A211147-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A211147-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A211147-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A211147-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-07-31 | 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 | A211147-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211147-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211147-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211147-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A211147-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211147-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211147-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211147-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211147-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211147-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211147-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211147-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211147-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211147-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211147-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211147-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211147-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211147-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A211147-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A211147-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211147-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211147-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211147-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211147-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211147-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211147-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A211147-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A211147-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211147-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211147-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A211147-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A211147-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A211147-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A211147-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A211147-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A211147-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A211147-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A211147-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A211147-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A211147-002 | AB | 1 | 782e0a99824c… |
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 |
|---|---|---|---|---|---|---|
| Azithromycin | AZITHROMYCIN | Preferred Pharmaceuticals Inc. | a1c96531-bbd2-4dc5-8eeb-3f0276cd0956 | 2026-03-11 | Warnings, Adverse reactions | 211147 ANDA211147 68788-8246 |
| Azithromycin | AZITHROMYCIN | Redpharm Drug | 3745a0b0-7855-69eb-e063-6294a90ab6a8 | 2025-12-24 | Warnings, Adverse reactions | 211147 ANDA211147 |
| Azithromycin | AZITHROMYCIN | Zydus Lifesciences Limited | 0b63649d-558c-4250-90ee-af6e1e5c6d2c | 2025-01-09 | 211147 ANDA211147 70771-1422 70771-1424 70771-1423 70771-1425 | |
| Azithromycin | AZITHROMYCIN | Zydus Pharmaceuticals USA Inc. | 99e5bd22-a721-4e2e-a46c-d61a53c25c3d | 2025-01-09 | Warnings, Adverse reactions | 211147 ANDA211147 70710-1460 70710-1458 70710-1457 70710-1459 |
| Azithromycin | AZITHROMYCIN | NuCare Pharmaceuticals,Inc. | 826f9c07-8eb9-a128-e053-2991aa0ad654 | 2024-06-14 | Warnings, Adverse reactions | 211147 ANDA211147 68071-4779 |
| Azithromycin | AZITHROMYCIN | A-S Medication Solutions | 5ed68b5a-4093-49f1-871b-7b0da5f7be2d | 2023-10-31 | Warnings, Adverse reactions | 211147 ANDA211147 50090-6267 |
| Azithromycin | AZITHROMYCIN | A-S Medication Solutions | 22a2bdcb-3012-42fb-ac66-d1d879100940 | 2023-02-06 | Warnings, Adverse reactions | 211147 ANDA211147 50090-4458 |
| Azithromycin | AZITHROMYCIN | Proficient Rx LP | 33140df5-420d-469f-b6c8-121e952a5cb6 | 2022-11-01 | Warnings, Adverse reactions | 211147 ANDA211147 71205-216 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-4458 | Azithromycin | Azithromycin | A-S Medication Solutions | ANDA | Current |
| 50090-4458 | Azithromycin | Azithromycin | A-S Medication Solutions | ANDA | Current |
| 50090-4458 | Azithromycin | Azithromycin | A-S Medication Solutions | ANDA | Current |
| 50090-6267 | Azithromycin | Azithromycin | A-S Medication Solutions | ANDA | Current |
| 68071-4711 | Azithromycin | Azithromycin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4711 | Azithromycin | Azithromycin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4779 | Azithromycin | Azithromycin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4779 | Azithromycin | Azithromycin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4779 | Azithromycin | Azithromycin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4785 | Azithromycin | Azithromycin | NuCare Pharmaceuticals,In | ANDA | Current |
| 68071-4785 | Azithromycin | Azithromycin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4785 | Azithromycin | Azithromycin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7307 | Azithromycin | Azithromycin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7307 | Azithromycin | Azithromycin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7320 | Azithromycin | Azithromycin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7320 | Azithromycin | Azithromycin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-8229 | Azithromycin | Azithromycin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8246 | Azithromycin | Azithromycin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-2075 | Azithromycin | Azithromycin | REMEDYREPACK INC. | ANDA | Current |
| 70710-1457 | Azithromycin | Azithromycin | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1457 | Azithromycin | Azithromycin | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1457 | Azithromycin | Azithromycin | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1457 | Azithromycin | Azithromycin | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1458 | Azithromycin | Azithromycin | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1458 | Azithromycin | Azithromycin | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1458 | Azithromycin | Azithromycin | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1458 | Azithromycin | Azithromycin | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1459 | Azithromycin | Azithromycin | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1459 | Azithromycin | Azithromycin | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1459 | Azithromycin | Azithromycin | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1459 | Azithromycin | Azithromycin | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1460 | Azithromycin | Azithromycin | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1460 | Azithromycin | Azithromycin | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1460 | Azithromycin | Azithromycin | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1460 | Azithromycin | Azithromycin | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70771-1422 | Azithromycin | Azithromycin | Cadila Healthcare Limited | ANDA | Current |
| 70771-1422 | Azithromycin | Azithromycin | Cadila Healthcare Limited | ANDA | Current |
| 70771-1422 | Azithromycin | Azithromycin | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1422 | Azithromycin | Azithromycin | Cadila Healthcare Limited | ANDA | Current |
| 70771-1423 | Azithromycin | Azithromycin | Cadila Healthcare Limited | ANDA | Current |
| 70771-1423 | Azithromycin | Azithromycin | Cadila Healthcare Limited | ANDA | Current |
| 70771-1423 | Azithromycin | Azithromycin | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1423 | Azithromycin | Azithromycin | Cadila Healthcare Limited | ANDA | Current |
| 70771-1424 | Azithromycin | Azithromycin | Cadila Healthcare Limited | ANDA | Current |
| 70771-1424 | Azithromycin | Azithromycin | Cadila Healthcare Limited | ANDA | Current |
| 70771-1424 | Azithromycin | Azithromycin | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1424 | Azithromycin | Azithromycin | Cadila Healthcare Limited | ANDA | Current |
| 70771-1425 | Azithromycin | Azithromycin | Cadila Healthcare Limited | ANDA | Current |
| 70771-1425 | Azithromycin | Azithromycin | Cadila Healthcare Limited | ANDA | Current |
| 70771-1425 | Azithromycin | Azithromycin | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1425 | Azithromycin | Azithromycin | Cadila Healthcare Limited | ANDA | Current |
| 71205-216 | Azithromycin | Azithromycin | Proficient Rx LP | ANDA | Current |
| 71205-216 | Azithromycin | Azithromycin | Proficient Rx LP | ANDA | Current |
| 71205-216 | Azithromycin | Azithromycin | Proficient Rx LP | ANDA | Current |