Application 089450
- Type
- ANDA
- Sponsor
- ANDA REPOSITORY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | SOLUTION;ORAL | 120MG/5ML;12MG/5ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | 1992-10-27 |
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 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | 1992-10-27 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | 1992-10-27 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | 1992-10-27 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | 1992-10-27 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A089450-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION / ORAL | AA | 1992-10-27 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A089450-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A089450-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A089450-001 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A089450-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A089450-001 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A089450-001 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A089450-001 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A089450-001 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A089450-001 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A089450-001 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A089450-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A089450-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A089450-001 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A089450-001 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A089450-001 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A089450-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A089450-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A089450-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A089450-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A089450-001 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A089450-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A089450-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A089450-001 | AA | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A089450-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A089450-001 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A089450-001 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A089450-001 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A089450-001 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A089450-001 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A089450-001 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A089450-001 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A089450-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A089450-001 | AA | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A089450-001 | AA | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A089450-001 | AA | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A089450-001 | AA | 1 | 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 |
|---|---|---|---|---|---|---|
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | REMEDYREPACK INC. | 4c966d73-77c6-4514-954e-57aa06a080c6 | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | REMEDYREPACK INC. | 1fe39679-fd58-4d2c-ba61-49d492a2b087 | 2026-07-27 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | SpecGx LLC | eadc80fa-13c3-471a-a22f-6fe7e1ab290f | 2026-06-12 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Unit Dose Solutions, Inc. | 537245e8-5e2a-c3e0-e063-6394a90ac858 | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | St. Mary's Medical Park Pharmacy | eac5f350-93e5-4dc2-e053-2a95a90aed60 | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Redpharm Drug | 52617668-acc3-65cd-e063-6294a90ab919 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Bryant Ranch Prepack | ff77a959-c77a-4911-8f7c-e2a3e24a6305 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Bryant Ranch Prepack | f308fd07-f004-42de-963d-426b268bba93 | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | Proficient Rx LP | 6980bfc5-15e4-48ec-9346-6f09f8f78900 | 2026-05-01 | Boxed warning, Warnings, Adverse reactions | Acetaminophen and Codeine Phosphate |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Bryant Ranch Prepack | e73b17c4-9f24-4b32-8920-61c58c40a714 | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Bryant Ranch Prepack | 879db1b5-6365-4151-9879-80d8a2a3cd8a | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Eywa Pharma Inc | 79377617-686b-4640-b2b8-e1358cf82358 | 2026-03-06 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | Genus Lifesciences Inc. | 95a5d638-3072-4c37-a4cd-f8550328e2c6 | 2026-02-25 | Boxed warning, Warnings, Adverse reactions | Acetaminophen and Codeine Phosphate |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | REMEDYREPACK INC. | 5c96d033-bf7c-47de-aa0d-5998b3bf4a63 | 2026-02-03 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | A-S Medication Solutions | 9ca1321e-380a-48d7-8a58-c6501858c1c0 | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | A-S Medication Solutions | dff53120-a609-4720-bd69-2391798c7dee | 2026-01-22 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | A-S Medication Solutions | 297dc9ff-e34f-434b-b1a4-4c995a5bac8b | 2026-01-22 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | ST. MARY'S MEDICAL PARK PHARMACY | 48eb36ee-e9dc-a719-e063-6394a90aa85e | 2026-01-21 | Boxed warning, Warnings, Adverse reactions | Acetaminophen and Codeine Phosphate |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Preferred Pharmaceuticals Inc. | 55d494b1-c828-4841-8f64-75b92cd54cb6 | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Preferred Pharmaceuticals Inc. | 2453d635-989d-4569-96b3-4efaf61cca71 | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | ACETAMINOPHEN AND CODEINE PHOSPHATE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 46672-561 | acetaminophen and codeine phosphate | acetaminophen and codeine phosphate | Mikart, LLC | ANDA | Current |
| 46672-561 | acetaminophen and codeine phosphate | acetaminophen and codeine phosphate | Mikart, Inc. | ANDA | Current |
| 46672-561 | acetaminophen and codeine phosphate | acetaminophen and codeine phosphate | Mikart, Inc. | ANDA | Current |
| 46672-561 | acetaminophen and codeine phosphate | acetaminophen and codeine phosphate | Mikart, LLC | ANDA | Current |
| 46672-561 | acetaminophen and codeine phosphate | acetaminophen and codeine phosphate | Mikart, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76115 | ORIG | 2023-11-02 |