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 | Chartwell Governmental & Specialty RX, LLC | 809393b7-6271-4715-ae84-13fd8f901772 | 2026-07-30 | Warnings, Adverse reactions | AMOXICILLIN |
| AMOXICILLIN | AMOXICILLIN | Chartwell RX, LLC | b07b5ac4-253e-4c83-91c3-3fdc46e91a0f | 2026-07-24 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals, Inc. | 4a402dba-c255-5db8-e054-00144ff8d46c | 2026-07-24 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | REMEDYREPACK INC. | a2c91cf0-a4e4-44c0-b712-bee63dd6c22b | 2026-07-22 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | REMEDYREPACK INC. | 102c62ca-da20-4866-84a8-e3513824af4a | 2026-07-21 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | REMEDYREPACK INC. | 9618d038-e880-47f6-b8d7-bbf8ab35364d | 2026-07-21 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 8cb987bf-d45a-c15a-e053-2995a90aad46 | 2026-07-21 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | HAWAII REPACK, INC. | bf130964-8386-4ab7-8d3b-fb0174670afc | 2026-07-17 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | PD-Rx Pharmaceuticals, Inc. | 18a4f555-a537-4c40-9bb2-dc3bd782fa27 | 2026-07-17 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Preferred Pharmaceuticals Inc. | ad804b34-169c-44bf-a469-f1149433d96b | 2026-07-15 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | PD-Rx Pharmaceuticals, Inc. | 96057ce7-9516-4239-9974-5e9691b44c9b | 2026-07-09 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Northwind Health Company, LLC | 1d0d8bc4-137e-ef10-e063-6294a90acf62 | 2026-07-09 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Northwind Health Company, LLC | 26e257d5-5b98-3795-e063-6394a90a05bc | 2026-07-09 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Northwind Health Company, LLC | 4ecefd37-9847-1d93-e063-6394a90a19f0 | 2026-07-09 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | USAntibiotics, LLC | 06e5c07d-d95c-4955-8d35-a4703ca2359e | 2026-07-07 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | HAWAII REPACK, INC. | 669a243e-249d-4ccb-9693-66de073e53bb | 2026-07-03 | Warnings, Adverse reactions | AMOXICILLIN |
| 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 |