Application 211318
- Type
- ANDA
- Sponsor
- YUNG SHIN PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AZITHROMYCIN | AZITHROMYCIN | TABLET;ORAL | EQ 500MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211318-001 | AZITHROMYCIN | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2021-03-17 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2021-03-17 | 87673890dc5c… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A211318-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | 2021-03-17 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2021-12-28 21:50 UTC | 2021-12 | A211318-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A211318-001 | AB | 1 | 87673890dc5c… |
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 | Direct_Rx | 8e6e11fb-eb9e-28ec-e053-2a95a90aa1a3 | 2025-01-22 | Warnings, Adverse reactions | AZITHROMYCIN AZITHROMYCIN |
| AZITHROMYCIN | AZITHROMYCIN | DirectRx | d564d91e-3039-c120-e053-2995a90ae6db | 2025-01-21 | Warnings, Adverse reactions | AZITHROMYCIN AZITHROMYCIN |
| Azithromycin | AZITHROMYCIN | Zydus Lifesciences Limited | 0b63649d-558c-4250-90ee-af6e1e5c6d2c | 2025-01-09 | Azithromycin AZITHROMYCIN | |
| Azithromycin | AZITHROMYCIN | Advanced Rx Pharmacy of Tennessee, LLC | f175496a-4ad3-ce0d-e053-2a95a90a6613 | 2024-12-31 | Warnings, Adverse reactions | Azithromycin AZITHROMYCIN |
| Azithromycin | AZITHROMYCIN MONOHYDRATE | Fresenius Kabi USA, LLC | b69917c0-95d5-4b29-b0e3-07054a4fd79f | 2024-10-11 | Warnings, Adverse reactions | Azithromycin |
| Azithromycin | AZITHROMYCIN MONOHYDRATE | Fresenius Kabi USA, LLC | 9ad099d5-5c57-4855-98a4-e03fb4629dbf | 2024-10-11 | Warnings, Adverse reactions | Azithromycin |
| Azithromycin | AZITHROMYCIN | Asclemed USA, Inc. | 22a4d2b3-daea-4d96-891f-4b9823629456 | 2024-10-04 | Warnings, Adverse reactions | Azithromycin AZITHROMYCIN |
| Azithromycin | AZITHROMYCIN | Proficient Rx LP | 90605f94-93e1-43d1-8be7-830e816ac84f | 2024-10-01 | Warnings, Adverse reactions | Azithromycin AZITHROMYCIN |
| Azithromycin | AZITHROMYCIN | Proficient Rx LP | 38942011-f86b-4e42-a4ca-05a70d9dd3d9 | 2024-10-01 | Warnings, Adverse reactions | Azithromycin AZITHROMYCIN |
| Azithromycin | AZITHROMYCIN MONOHYDRATE | Sagent Pharmaceuticals | 6497fb5e-82d8-4411-b994-7ee01333ffd7 | 2024-09-19 | Warnings, Adverse reactions | Azithromycin |
| Azithromycin | AZITHROMYCIN | A-S Medication Solutions | f97d2e7e-ccfd-4f04-85ba-549b37f6aa7b | 2024-07-22 | Warnings, Adverse reactions | Azithromycin AZITHROMYCIN |
| Azithromycin | AZITHROMYCIN | NuCare Pharmaceuticals,Inc. | b0138503-ddc4-2e1c-e053-2995a90a0d2d | 2024-07-17 | Warnings, Adverse reactions | Azithromycin AZITHROMYCIN |
| Azithromycin | AZITHROMYCIN | NuCare Pharmaceuticals,Inc. | b43d23c7-1a2e-ce93-e053-2995a90a65a4 | 2024-07-17 | Warnings, Adverse reactions | Azithromycin AZITHROMYCIN |
| Azithromycin | AZITHROMYCIN | NuCare Pharmaceuticals,Inc. | 549cdd0a-da79-23b8-e054-00144ff8d46c | 2024-07-17 | Warnings, Adverse reactions | Azithromycin AZITHROMYCIN |
| AZITHROMYCIN | AZITHROMYCIN | NuCare Pharmaceuticals,Inc. | 90a506cd-aae7-a622-e053-2a95a90ad352 | 2024-06-19 | Warnings, Adverse reactions | AZITHROMYCIN AZITHROMYCIN |
| Azithromycin | AZITHROMYCIN | NuCare Pharmaceuticals,Inc. | 9270e676-3382-6483-e053-2a95a90a556e | 2024-06-19 | Warnings, Adverse reactions | Azithromycin AZITHROMYCIN |
| Azithromycin | AZITHROMYCIN | NuCare Pharmaceuticals,Inc. | 8e7184e1-3c3c-cd87-e053-2a95a90a6eb6 | 2024-06-18 | Warnings, Adverse reactions | Azithromycin AZITHROMYCIN |
| AZITHROMYCIN | AZITHROMYCIN | NuCare Pharmaceuticals,Inc. | 82454fb2-e524-ecb8-e053-2991aa0a6e7c | 2024-06-14 | Warnings, Adverse reactions | AZITHROMYCIN AZITHROMYCIN |
| Azithromycin | AZITHROMYCIN | NuCare Pharmaceuticals,Inc. | 826f9c07-8eb9-a128-e053-2991aa0ad654 | 2024-06-14 | Warnings, Adverse reactions | Azithromycin AZITHROMYCIN |
| AZITHROMYCIN | AZITHROMYCIN | NuCare Pharmaceuticals,Inc. | 8389c336-25eb-a96f-e053-2a91aa0a0dd8 | 2024-06-14 | Warnings, Adverse reactions | AZITHROMYCIN AZITHROMYCIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.