Application 207531
- Type
- ANDA
- Sponsor
- EPIC PHARMA LLC
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 |
|---|---|---|---|---|---|---|---|
| A207531-001 | AZITHROMYCIN | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | |
| A207531-002 | AZITHROMYCIN | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207531-001 | AB |
| A207531-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A207531-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207531-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207531-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207531-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207531-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207531-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207531-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207531-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207531-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207531-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207531-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207531-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207531-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207531-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207531-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207531-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207531-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207531-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207531-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207531-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207531-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207531-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207531-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207531-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207531-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207531-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207531-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207531-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A207531-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A207531-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207531-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207531-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A207531-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A207531-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A207531-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A207531-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A207531-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A207531-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A207531-001 | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A207531-002 | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2018-04-09 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A207531-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207531-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A207531-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207531-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207531-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207531-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A207531-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207531-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207531-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207531-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207531-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207531-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207531-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207531-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207531-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207531-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207531-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207531-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207531-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207531-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A207531-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207531-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207531-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207531-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207531-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207531-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207531-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207531-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A207531-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A207531-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207531-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207531-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A207531-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A207531-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A207531-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A207531-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A207531-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A207531-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A207531-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A207531-002 | AB | 1 | bb7c543d1eb4… |
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 | A-S Medication Solutions | 76093152-e2d7-4fe1-8568-1f0fec1747c2 | 2026-07-01 | Warnings, Adverse reactions | 207531 ANDA207531 |
| AZITHROMYCIN | AZITHROMYCIN | Preferred Pharmaceuticals, Inc. | 9e4fbd52-43e4-4d87-a136-f4d680a8d0c1 | 2026-03-12 | Warnings, Adverse reactions | 207531 ANDA207531 68788-7549 |
| AZITHROMYCIN | AZITHROMYCIN | A-S Medication Solutions | 405ab07f-7d1d-4552-ad3b-2a03be8e9949 | 2026-02-17 | Warnings, Adverse reactions | 207531 ANDA207531 50090-6296 |
| AZITHROMYCIN | AZITHROMYCIN | Epic Pharma, LLC | 59c4b783-4ff7-4269-969b-58a10e12b12b | 2026-02-04 | Warnings, Adverse reactions | 207531 ANDA207531 42806-147 42806-150 42806-149 42806-151 |
| AZITHROMYCIN | AZITHROMYCIN | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 714f6f55-278a-4fcf-8d4e-2ad9b43623a3 | 2025-11-20 | Warnings, Adverse reactions | 207531 ANDA207531 24658-706 24658-708 |
| AZITHROMYCIN | AZITHROMYCIN | NuCare Pharmaceuticals, Inc. | 3f7c7421-411d-c04e-e063-6394a90a4aa0 | 2025-09-23 | Warnings, Adverse reactions | 207531 ANDA207531 |
| AZITHROMYCIN | AZITHROMYCIN | DirectRx | d564d91e-3039-c120-e053-2995a90ae6db | 2025-01-21 | Warnings, Adverse reactions | 207531 ANDA207531 72189-314 |
| AZITHROMYCIN | AZITHROMYCIN | NuCare Pharmaceuticals,Inc. | 90a506cd-aae7-a622-e053-2a95a90ad352 | 2024-06-19 | Warnings, Adverse reactions | 207531 ANDA207531 68071-5035 |
| AZITHROMYCIN | AZITHROMYCIN | NuCare Pharmaceuticals,Inc. | 82454fb2-e524-ecb8-e053-2991aa0a6e7c | 2024-06-14 | Warnings, Adverse reactions | 207531 ANDA207531 68071-4773 |
| AZITHROMYCIN | AZITHROMYCIN | NuCare Pharmaceuticals,Inc. | 8389c336-25eb-a96f-e053-2a91aa0a0dd8 | 2024-06-14 | Warnings, Adverse reactions | 207531 ANDA207531 68071-4795 |
| AZITHROMYCIN | AZITHROMYCIN | Proficient Rx LP | e1172805-0930-4fb9-8a2f-e0d6a0430630 | 2022-11-01 | Warnings, Adverse reactions | 207531 ANDA207531 71205-566 |
| AZITHROMYCIN | AZITHROMYCIN | Proficient Rx LP | b3761d39-9b79-4908-8b05-a1c91e599998 | 2022-11-01 | Warnings, Adverse reactions | 207531 ANDA207531 71205-253 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 24658-706 | AZITHROMYCIN | AZITHROMYCIN | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | ANDA | Current |
| 24658-706 | AZITHROMYCIN | AZITHROMYCIN | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | ANDA | Current |
| 24658-708 | AZITHROMYCIN | AZITHROMYCIN | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | ANDA | Current |
| 24658-708 | AZITHROMYCIN | AZITHROMYCIN | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | ANDA | Current |
| 42806-147 | AZITHROMYCIN | AZITHROMYCIN | Epic Pharma, LLC | ANDA | Current |
| 42806-147 | AZITHROMYCIN | AZITHROMYCIN | Epic Pharma, LLC | ANDA | Current |
| 42806-147 | AZITHROMYCIN | AZITHROMYCIN | Epic Pharma, LLC | ANDA | Current |
| 42806-147 | AZITHROMYCIN | azithromycin | Epic Pharma, LLC | ANDA | Current |
| 42806-149 | AZITHROMYCIN | AZITHROMYCIN | Epic Pharma, LLC | ANDA | Current |
| 42806-149 | AZITHROMYCIN | AZITHROMYCIN | Epic Pharma, LLC | ANDA | Current |
| 42806-149 | AZITHROMYCIN | AZITHROMYCIN | Epic Pharma, LLC | ANDA | Current |
| 42806-149 | AZITHROMYCIN | azithromycin | Epic Pharma, LLC | ANDA | Current |
| 42806-150 | AZITHROMYCIN | AZITHROMYCIN | Epic Pharma, LLC | ANDA | Current |
| 42806-150 | AZITHROMYCIN | AZITHROMYCIN | Epic Pharma, LLC | ANDA | Current |
| 42806-150 | AZITHROMYCIN | AZITHROMYCIN | Epic Pharma, LLC | ANDA | Current |
| 42806-150 | AZITHROMYCIN | azithromycin | Epic Pharma, LLC | ANDA | Current |
| 42806-151 | AZITHROMYCIN | AZITHROMYCIN | Epic Pharma, LLC | ANDA | Current |
| 42806-151 | AZITHROMYCIN | AZITHROMYCIN | Epic Pharma, LLC | ANDA | Current |
| 42806-151 | AZITHROMYCIN | AZITHROMYCIN | Epic Pharma, LLC | ANDA | Current |
| 42806-151 | AZITHROMYCIN | azithromycin | Epic Pharma, LLC | ANDA | Current |
| 50090-6296 | AZITHROMYCIN | azithromycin | A-S Medication Solutions | ANDA | Current |
| 53002-2231 | AZITHROMYCIN | AZITHROMYCIN | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55700-731 | AZITHROMYCIN | AZITHROMYCIN | Quality Care Products LLC | ANDA | Current |
| 55700-731 | AZITHROMYCIN | AZITHROMYCIN | Quality Care Products LLC | ANDA | Current |
| 55700-731 | AZITHROMYCIN | AZITHROMYCIN | Quality Care Products LLC | ANDA | Current |
| 55700-784 | AZITHROMYCIN | AZITHROMYCIN | Quality Care Products, LLC | ANDA | Current |
| 55700-784 | AZITHROMYCIN | AZITHROMYCIN | Quality Care Products, LLC | ANDA | Current |
| 68071-4773 | AZITHROMYCIN | AZITHROMYCIN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4773 | AZITHROMYCIN | AZITHROMYCIN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4773 | AZITHROMYCIN | AZITHROMYCIN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4773 | AZITHROMYCIN | AZITHROMYCIN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4795 | AZITHROMYCIN | AZITHROMYCIN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4795 | AZITHROMYCIN | AZITHROMYCIN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5035 | AZITHROMYCIN | AZITHROMYCIN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5035 | AZITHROMYCIN | AZITHROMYCIN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7549 | AZITHROMYCIN | AZITHROMYCIN | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7549 | AZITHROMYCIN | AZITHROMYCIN | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7549 | AZITHROMYCIN | AZITHROMYCIN | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7549 | AZITHROMYCIN | AZITHROMYCIN | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7636 | AZITHROMYCIN | AZITHROMYCIN | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7636 | AZITHROMYCIN | AZITHROMYCIN | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7636 | AZITHROMYCIN | AZITHROMYCIN | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 71205-253 | AZITHROMYCIN | AZITHROMYCIN | Proficient Rx LP | ANDA | Current |
| 71205-253 | AZITHROMYCIN | AZITHROMYCIN | Proficient Rx LP | ANDA | Current |
| 71205-253 | AZITHROMYCIN | AZITHROMYCIN | Proficient Rx LP | ANDA | Current |
| 71205-253 | AZITHROMYCIN | AZITHROMYCIN | Proficient Rx LP | ANDA | Current |
| 71205-566 | AZITHROMYCIN | AZITHROMYCIN | Proficient Rx LP | ANDA | Current |
| 71205-566 | AZITHROMYCIN | AZITHROMYCIN | Proficient Rx LP | ANDA | Current |
| 72189-314 | AZITHROMYCIN | AZITHROMYCIN | DirectRx | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 48647 | ORIG | 2017-06-06 |