Application 065159
- Type
- ANDA
- Sponsor
- RANBAXY LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DISPERMOX | AMOXICILLIN | TABLET, FOR SUSPENSION;ORAL | 600MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065159-001 | DISPERMOX | AMOXICILLIN | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 |
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 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A065159-001 | DISPERMOX | 600MG | TABLET, FOR SUSPENSION / ORAL | 2003-12-04 | 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 |
|---|---|---|---|---|---|---|
| Amoxicillin | AMOXICILLIN | REMEDYREPACK INC. | 53548597-347b-42a9-916c-e88cd27b8dcd | 2026-07-01 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 60c7ae87-9631-4b29-9ca4-82fb3bafcab8 | 2026-06-22 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | REMEDYREPACK INC. | f37eb415-77b2-41b0-8d20-64e821e4b05d | 2026-06-10 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | REMEDYREPACK INC. | 3a4afd36-dffa-44a1-9d09-e93cf66053bf | 2026-06-09 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Proficient Rx LP | 313ea909-5b1b-41ff-a0db-5aadc12e2e4f | 2026-06-01 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Proficient Rx LP | ef03286b-4ba7-4952-9ab1-90cacf300504 | 2026-06-01 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Coupler LLC | 52bd03c6-528a-c443-e063-6394a90aad39 | 2026-05-26 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 5155ca5d-fe58-42b4-e063-6394a90ab135 | 2026-05-21 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Bryant Ranch Prepack | be7d8459-b8e6-499a-ab87-99bd17492525 | 2026-05-08 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | QPharma, Inc | 60c788d1-6c91-4456-848a-893e649e90be | 2026-05-08 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | QPharma Inc | ddd1307d-3216-0e59-e053-2995a90ad19d | 2026-05-08 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Coupler LLC | 50fff2b8-8bf1-ff46-e063-6394a90a9213 | 2026-05-04 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Coupler LLC | 5037e2a5-52e9-caec-e063-6294a90ad837 | 2026-04-28 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Coupler LLC | 5020950a-b248-a463-e063-6294a90ae57f | 2026-04-23 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | American Health Packaging | d339ea0f-8797-460f-a3b7-b8455c250366 | 2026-04-07 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Sportpharm LLC | 9bb2856b-feef-4063-befc-2dd917502898 | 2026-03-20 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | c19b533a-907a-6350-e053-2a95a90a1244 | 2026-03-13 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Preferred Pharmaceuticals Inc. | afef7c71-2d19-41ed-9213-b32ccc1bf1d3 | 2026-03-04 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Preferred Pharmaceuticals Inc. | 4b23e6f5-9287-4c01-b795-b8c538833039 | 2026-03-04 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Preferred Pharmaceuticals Inc. | c0e333d9-164d-4196-b5f5-929993d1c3c2 | 2026-03-04 | Warnings, Adverse reactions | AMOXICILLIN |