Application 050711
- Type
- NDA
- Sponsor
- PFIZER
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZITHROMAX | AZITHROMYCIN | TABLET;ORAL | EQ 250MG BASE | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050711-001 | ZITHROMAX | AZITHROMYCIN | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N050711-001 | 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 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N050711-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050711-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N050711-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050711-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050711-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050711-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050711-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050711-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050711-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N050711-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050711-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050711-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050711-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N050711-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050711-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N050711-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N050711-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N050711-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N050711-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N050711-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N050711-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N050711-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N050711-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N050711-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N050711-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N050711-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N050711-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N050711-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N050711-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N050711-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N050711-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N050711-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N050711-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N050711-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N050711-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N050711-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N050711-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N050711-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N050711-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N050711-001 | AB | 1 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| Zithromax | AZITHROMYCIN DIHYDRATE | Pfizer Laboratories Div Pfizer Inc | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 2026-07-24 | Warnings, Adverse reactions | 050711 NDA050711 0069-3060 0069-4061 |
| Zithromax | AZITHROMYCIN DIHYDRATE | Redpharm Drug | 3ddecd25-dc32-a2af-e063-6294a90a526d | 2025-09-03 | Warnings, Adverse reactions | 050711 NDA050711 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0069-3060 | Zithromax | azithromycin dihydrate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-3060 | Zithromax | azithromycin dihydrate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-3060 | Zithromax | azithromycin dihydrate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-3060 | Zithromax | azithromycin dihydrate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-3060 | Zithromax | azithromycin dihydrate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-3060 | Zithromax | azithromycin dihydrate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-3060 | Zithromax | azithromycin dihydrate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-3060 | Zithromax | azithromycin dihydrate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-3060 | Zithromax | azithromycin dihydrate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-3060 | Zithromax | azithromycin dihydrate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-3060 | Zithromax | azithromycin dihydrate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-4061 | Zithromax | azithromycin dihydrate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-4061 | Zithromax | azithromycin dihydrate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-4061 | Zithromax | azithromycin dihydrate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-4061 | Zithromax | azithromycin dihydrate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-4061 | Zithromax | azithromycin dihydrate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-4061 | Zithromax | azithromycin dihydrate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-4061 | Zithromax | azithromycin dihydrate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-4061 | Zithromax | azithromycin dihydrate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-4061 | Zithromax | azithromycin dihydrate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-4061 | Zithromax | azithromycin dihydrate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 50090-0603 | Zithromax | azithromycin dihydrate | A-S Medication Solutions | NDA | Current |
| 50090-0603 | Zithromax | azithromycin dihydrate | A-S Medication Solutions | NDA | Current |
| 55154-0525 | azithromycin | azithromycin | Cardinal Health | NDA AUTHORIZED GENERIC | Current |
| 55154-2713 | Zithromax | azithromycin | Cardinal Health | NDA | Current |
| 55695-006 | azithromycin | azithromycin | Department of State Health Services, Pharmacy Branch | NDA AUTHORIZED GENERIC | Current |
| 55700-206 | azithromycin | azithromycin | Lake Erie Medical DBA Quality Care Products LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2198 | azithromycin | azithromycin | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2198 | azithromycin | azithromycin | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2198 | azithromycin | azithromycin | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2198 | azithromycin | azithromycin | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2198 | azithromycin | azithromycin | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2198 | azithromycin | azithromycin | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2198 | azithromycin | azithromycin | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2198 | azithromycin | azithromycin | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2198 | azithromycin | azithromycin | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2198 | azithromycin | azithromycin | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2198 | azithromycin | azithromycin | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-3060 | azithromycin | azithromycin | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-3060 | azithromycin | azithromycin | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-3060 | azithromycin | azithromycin | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-3060 | azithromycin | azithromycin | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-3060 | azithromycin | azithromycin | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-3060 | azithromycin | azithromycin | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-3060 | azithromycin | azithromycin | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-3060 | azithromycin | azithromycin | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 68071-2543 | azithromycin | azithromycin | NuCare Pharmaceuticals,Inc. | NDA AUTHORIZED GENERIC | Current |
| 68788-9038 | azithromycin | azithromycin | Preferred Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 68788-9038 | azithromycin | azithromycin | Preferred Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 70518-0249 | Zithromax | azithromycin dihydrate | REMEDYREPACK INC. | NDA | Current |
| 70518-0249 | Zithromax | azithromycin dihydrate | REMEDYREPACK INC. | NDA | Current |
| 70518-0249 | Zithromax | azithromycin dihydrate | REMEDYREPACK INC. | NDA | Current |
| 70518-0249 | Zithromax | azithromycin dihydrate | REMEDYREPACK INC. | NDA | Current |
| 70518-0249 | Zithromax | azithromycin dihydrate | REMEDYREPACK INC. | NDA | Current |
| 70518-0505 | Zithromax | azithromycin dihydrate | REMEDYREPACK INC. | NDA | Current |
| 70518-0505 | Zithromax | azithromycin dihydrate | REMEDYREPACK INC. | NDA | Current |
| 70518-0505 | Zithromax | azithromycin dihydrate | REMEDYREPACK INC. | NDA | Current |
| 70518-0505 | Zithromax | azithromycin dihydrate | REMEDYREPACK INC. | NDA | Current |
| 70518-0505 | Zithromax | azithromycin dihydrate | REMEDYREPACK INC. | NDA | Current |
| 70518-2708 | azithromycin | azithromycin | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |
| 70518-2708 | azithromycin | azithromycin | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |
| 70518-2708 | azithromycin | azithromycin | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |
| 70518-2708 | azithromycin | azithromycin | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |
| 71610-381 | azithromycin | azithromycin | Aphena Pharma Solutions - Tennessee, LLC | NDA AUTHORIZED GENERIC | Current |
| 76413-101 | azithromycin | azithromycin | Central Texas Community Health Centers | NDA AUTHORIZED GENERIC | Current |
| 76413-102 | azithromycin | azithromycin | Central Texas Community Health Centers | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 70171 | SUPPL | 2022-02-15 |
| 69418 | SUPPL | 2021-11-24 |
| 69372 | SUPPL | 2021-11-22 |
| 58419 | SUPPL | 2019-04-25 |
| 58396 | SUPPL | 2019-04-24 |
| 47834 | SUPPL | 2017-04-03 |
| 47797 | SUPPL | 2017-03-31 |
| 47189 | SUPPL | 2017-02-13 |
| 47173 | SUPPL | 2017-02-13 |
| 18083 | SUPPL | 2016-05-25 |
| 8075 | SUPPL | 2016-05-25 |
| 30336 | SUPPL | 2014-06-11 |
| 18080 | SUPPL | 2014-06-10 |
| 23723 | ORIG | 2013-03-12 |
| 30338 | SUPPL | 2013-02-21 |
| 18082 | SUPPL | 2013-02-21 |
| 30335 | SUPPL | 2012-11-06 |
| 18079 | SUPPL | 2012-11-06 |
| 18081 | SUPPL | 2012-06-11 |
| 30337 | SUPPL | 2012-06-08 |
| 18078 | SUPPL | 2011-02-04 |
| 8074 | SUPPL | 2011-02-03 |
| 39162 | SUPPL | 2010-08-19 |
| 30334 | SUPPL | 2010-08-17 |
| 18077 | SUPPL | 2009-04-03 |
| 8073 | SUPPL | 2009-03-03 |
| 8072 | SUPPL | 2007-11-08 |
| 39161 | SUPPL | 2007-11-07 |
| 22194 | ORIG | 2005-08-04 |
| 42687 | SUPPL | 2004-06-04 |
| 39160 | SUPPL | 2004-01-22 |
| 39159 | SUPPL | 2004-01-22 |
| 30332 | SUPPL | 2004-01-22 |
| 8071 | SUPPL | 2004-01-22 |
| 30333 | SUPPL | 2003-12-22 |
| 30330 | SUPPL | 2002-10-16 |
| 8070 | SUPPL | 2002-07-22 |
| 30331 | SUPPL | 2002-05-24 |
| 18076 | SUPPL | 2002-05-24 |