Application 050813
- Type
- NDA
- Sponsor
- PRAGMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MOXATAG | AMOXICILLIN | TABLET, EXTENDED RELEASE;ORAL | 775MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050813-001 | MOXATAG | AMOXICILLIN | 775MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-01-23 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N050813-001 | 8357394 | 2026-12-08 | Drug product | 2013-01-30 | |
| N050813-001 | 8778924 | 2026-12-08 | U-897 | Drug substance, Drug product | 2015-06-17 |
| N050813-001 | 8299052 | 2027-05-07 | U-1304 | 2012-12-03 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N050813-001 | MOXATAG | 775MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-01-23 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N050813-001 | MOXATAG | 775MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-01-23 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N050813-001 | MOXATAG | 775MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-01-23 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N050813-001 | MOXATAG | 775MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-01-23 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N050813-001 | 8357394 | 2026-12-08 | Drug product | 2013-01-30 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N050813-001 | 8778924 | 2026-12-08 | U-897 | Drug substance, Drug product | 2015-06-17 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N050813-001 | 8299052 | 2027-05-07 | U-1304 | 2012-12-03 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N050813-001 | 8357394 | 2026-12-08 | Drug product | 2013-01-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N050813-001 | 8778924 | 2026-12-08 | U-897 | Drug substance, Drug product | 2015-06-17 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N050813-001 | 8299052 | 2027-05-07 | U-1304 | 2012-12-03 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N050813-001 | 8357394 | 2026-12-08 | Drug product | 2013-01-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050813-001 | 8778924 | 2026-12-08 | U-897 | Drug substance, Drug product | 2015-06-17 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N050813-001 | 8299052 | 2027-05-07 | U-1304 | 2012-12-03 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050813-001 | 8357394 | 2026-12-08 | Drug product | 2013-01-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050813-001 | 8778924 | 2026-12-08 | U-897 | Drug substance, Drug product | 2015-06-17 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N050813-001 | 8299052 | 2027-05-07 | U-1304 | 2012-12-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050813-001 | 8357394 | 2026-12-08 | Drug product | 2013-01-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050813-001 | 8778924 | 2026-12-08 | U-897 | Drug substance, Drug product | 2015-06-17 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050813-001 | 8299052 | 2027-05-07 | U-1304 | 2012-12-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050813-001 | 8357394 | 2026-12-08 | Drug product | 2013-01-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050813-001 | 8778924 | 2026-12-08 | U-897 | Drug substance, Drug product | 2015-06-17 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N050813-001 | 8299052 | 2027-05-07 | U-1304 | 2012-12-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050813-001 | 8357394 | 2026-12-08 | Drug product | 2013-01-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050813-001 | 8778924 | 2026-12-08 | U-897 | Drug substance, Drug product | 2015-06-17 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050813-001 | 8299052 | 2027-05-07 | U-1304 | 2012-12-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050813-001 | 8357394 | 2026-12-08 | Drug product | 2013-01-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050813-001 | 8778924 | 2026-12-08 | U-897 | Drug substance, Drug product | 2015-06-17 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050813-001 | 8299052 | 2027-05-07 | U-1304 | 2012-12-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050813-001 | 8357394 | 2026-12-08 | Drug product | 2013-01-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050813-001 | 8778924 | 2026-12-08 | U-897 | Drug substance, Drug product | 2015-06-17 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050813-001 | 8299052 | 2027-05-07 | U-1304 | 2012-12-03 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050813-001 | 8357394 | 2026-12-08 | Drug product | 2013-01-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050813-001 | 8778924 | 2026-12-08 | U-897 | Drug substance, Drug product | 2015-06-17 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050813-001 | 8299052 | 2027-05-07 | U-1304 | 2012-12-03 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050813-001 | 8357394 | 2026-12-08 | Drug product | 2013-01-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050813-001 | 8778924 | 2026-12-08 | U-897 | Drug substance, Drug product | 2015-06-17 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050813-001 | 8299052 | 2027-05-07 | U-1304 | 2012-12-03 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050813-001 | 8357394 | 2026-12-08 | Drug product | 2013-01-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050813-001 | 8778924 | 2026-12-08 | U-897 | Drug substance, Drug product | 2015-06-17 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050813-001 | 8299052 | 2027-05-07 | U-1304 | 2012-12-03 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050813-001 | 8357394 | 2026-12-08 | Drug product | 2013-01-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050813-001 | 8778924 | 2026-12-08 | U-897 | Drug substance, Drug product | 2015-06-17 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N050813-001 | 8299052 | 2027-05-07 | U-1304 | 2012-12-03 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050813-001 | 8357394 | 2026-12-08 | Drug product | 2013-01-30 | 79d66fd596c7… |
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. | 4adc198e-39d8-4b3e-bfa4-278aaf4064ae | 2026-09-09 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | REMEDYREPACK INC. | b6ea2f81-aee6-4c88-b681-50eb28e80a86 | 2026-09-03 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Redpharm Drug | 5a79669f-52f7-e8ea-e063-6394a90a93b8 | 2026-09-02 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | REMEDYREPACK INC. | f37eb415-77b2-41b0-8d20-64e821e4b05d | 2026-09-02 | Warnings, Adverse reactions | AMOXICILLIN |
| AMOXICILLIN | AMOXICILLIN | Redpharm Drug | 5a660370-9a81-33f9-e063-6394a90a6c62 | 2026-09-01 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Sportpharm LLC | c4d4aeca-f63c-4548-a9b7-7f627e8fd45c | 2026-08-29 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | REMEDYREPACK INC. | 82c0c5d1-df2d-4352-bd12-99f955af569e | 2026-08-20 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | REMEDYREPACK INC. | 3a4afd36-dffa-44a1-9d09-e93cf66053bf | 2026-08-20 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 452eb254-028a-4e02-9cb0-85483a4abaf5 | 2026-08-10 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | REMEDYREPACK INC. | afb4149a-0714-4a85-b9e8-2379a8e6a302 | 2026-08-06 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Coupler LLC | 5827b6de-6b48-d73a-e063-6394a90a4a72 | 2026-08-03 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 8cb987bf-d45a-c15a-e053-2995a90aad46 | 2026-08-03 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Redpharm Drug | 57f5652d-ee50-eb7e-e063-6394a90a7b66 | 2026-08-01 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Redpharm Drug | 57e56202-950b-10f6-e063-6394a90a4912 | 2026-07-31 | 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 | 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69442-030 | MOXATAG | amoxicillin | Vernalis Therapeutics, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 78380 | SUPPL | 2024-05-03 |
| 78356 | SUPPL | 2024-05-02 |
| 71098 | SUPPL | 2022-05-19 |
| 71092 | SUPPL | 2022-05-18 |
| 69822 | SUPPL | 2022-01-07 |
| 60809 | SUPPL | 2019-11-12 |
| 18294 | SUPPL | 2019-06-05 |
| 8334 | SUPPL | 2015-06-10 |
| 42751 | ORIG | 2010-03-26 |
| 24347 | ORIG | 2010-03-26 |
| 8333 | ORIG | 2008-01-25 |
| 39380 | ORIG | 2008-01-24 |
| 53173 | ORIG | 1900-01-01 |
| 53172 | ORIG | 1900-01-01 |
| 53171 | ORIG | 1900-01-01 |