Application 211610
- Type
- ANDA
- Sponsor
- EYWA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | TABLET;ORAL | 300MG;15MG | No | No |
| 002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | TABLET;ORAL | 300MG;30MG | No | No |
| 003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | TABLET;ORAL | 300MG;60MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211610-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | 2019-06-27 | |
| A211610-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | 2019-06-27 | |
| A211610-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | 2019-06-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A211610-001 | AA |
| A211610-002 | AA |
| A211610-003 | AA |
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 | A211610-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | 2019-06-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211610-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | 2019-06-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211610-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | 2019-06-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211610-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | 2019-06-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211610-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | 2019-06-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211610-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | 2019-06-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211610-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | 2019-06-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211610-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | 2019-06-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211610-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | 2019-06-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211610-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | 2019-06-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211610-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | 2019-06-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211610-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | 2019-06-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211610-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | 2019-06-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211610-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | 2019-06-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211610-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | 2019-06-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211610-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | 2019-06-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211610-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | 2019-06-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211610-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | 2019-06-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211610-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | 2019-06-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211610-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | 2019-06-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211610-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | 2019-06-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211610-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | 2019-06-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211610-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | 2019-06-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211610-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | 2019-06-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211610-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | 2019-06-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211610-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | 2019-06-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211610-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | 2019-06-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A211610-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | 2019-06-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A211610-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | 2019-06-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A211610-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | 2019-06-27 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211610-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | 2019-06-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211610-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | 2019-06-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211610-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | 2019-06-27 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211610-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | 2019-06-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211610-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | 2019-06-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211610-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | 2019-06-27 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211610-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | 2019-06-27 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211610-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | 2019-06-27 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211610-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | 2019-06-27 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A211610-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | 2019-06-27 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A211610-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211610-002 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211610-003 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211610-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211610-002 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211610-003 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A211610-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211610-002 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211610-003 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211610-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211610-002 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211610-003 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211610-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211610-002 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211610-003 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211610-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211610-002 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211610-003 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211610-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211610-002 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211610-003 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211610-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211610-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211610-003 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211610-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211610-002 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211610-003 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A211610-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A211610-002 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A211610-003 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211610-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211610-002 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211610-003 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211610-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211610-002 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211610-003 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211610-001 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211610-002 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211610-003 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A211610-001 | AA | 1 | 8072bd15b7f6… |
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 | 211610 ANDA211610 70518-2764 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | REMEDYREPACK INC. | 1fe39679-fd58-4d2c-ba61-49d492a2b087 | 2026-07-27 | Boxed warning, Warnings, Adverse reactions | 211610 ANDA211610 70518-2628 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Redpharm Drug | 52617668-acc3-65cd-e063-6294a90ab919 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | 211610 ANDA211610 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Bryant Ranch Prepack | ff77a959-c77a-4911-8f7c-e2a3e24a6305 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | 211610 ANDA211610 71335-1846 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Bryant Ranch Prepack | f308fd07-f004-42de-963d-426b268bba93 | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | 211610 ANDA211610 71335-1818 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Bryant Ranch Prepack | e73b17c4-9f24-4b32-8920-61c58c40a714 | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | 211610 ANDA211610 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Bryant Ranch Prepack | 879db1b5-6365-4151-9879-80d8a2a3cd8a | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | 211610 ANDA211610 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Eywa Pharma Inc | 79377617-686b-4640-b2b8-e1358cf82358 | 2026-03-06 | Boxed warning, Warnings, Adverse reactions | 211610 ANDA211610 71930-055 71930-054 71930-056 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Asclemed USA, Inc. | 682ef287-647a-4d89-9bbf-75907ebd10f2 | 2025-08-17 | Boxed warning, Warnings, Adverse reactions | 211610 ANDA211610 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Preferred Pharmaceuticals Inc. | 7ab27392-9c6e-4ec3-85e7-06b43fcab3b1 | 2025-06-02 | Boxed warning, Warnings, Adverse reactions | 211610 ANDA211610 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | NuCare Pharmaceuticals, Inc. | 1e932a34-a7d3-e4ec-e063-6294a90a25b1 | 2025-01-14 | Boxed warning, Warnings, Adverse reactions | 211610 ANDA211610 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | NuCare Pharmaceuticals, Inc. | 1e01f923-38c1-9b59-e063-6394a90a22f1 | 2024-07-24 | Boxed warning, Warnings, Adverse reactions | 211610 ANDA211610 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Bryant Ranch Prepack | ebdbc975-4e0e-4b83-8cf4-f29da829113a | 2024-01-09 | Boxed warning, Warnings, Adverse reactions | 211610 ANDA211610 63629-1190 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-5198 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | A-S Medication Solutions | ANDA | Current |
| 50090-5198 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | A-S Medication Solutions | ANDA | Current |
| 50090-5198 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | A-S Medication Solutions | ANDA | Current |
| 50090-5200 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | A-S Medication Solutions | ANDA | Current |
| 50090-5200 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | A-S Medication Solutions | ANDA | Current |
| 50090-5200 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | A-S Medication Solutions | ANDA | Current |
| 50090-5201 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | A-S Medication Solutions | ANDA | Current |
| 50090-5201 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | A-S Medication Solutions | ANDA | Current |
| 50090-5201 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | A-S Medication Solutions | ANDA | Current |
| 50090-5204 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | A-S Medication Solutions | ANDA | Current |
| 50090-5204 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | A-S Medication Solutions | ANDA | Current |
| 63629-1185 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1185 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1185 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1186 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1187 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1187 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1187 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1188 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1188 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1188 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1188 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1189 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1190 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1190 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1190 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Bryant Ranch Prepack | ANDA | Current |
| 68071-2681 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7801 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7801 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7801 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7802 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7802 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7802 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-2628 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2628 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2628 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2764 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2764 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2764 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | REMEDYREPACK INC. | ANDA | Current |
| 71335-1818 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1846 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Bryant Ranch Prepack | ANDA | Current |
| 71930-054 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Eywa Pharma Inc | ANDA | Current |
| 71930-054 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Eywa Pharma Inc | ANDA | Current |
| 71930-055 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Eywa Pharma Inc | ANDA | Current |
| 71930-055 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Eywa Pharma Inc | ANDA | Current |
| 71930-056 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Eywa Pharma Inc | ANDA | Current |
| 71930-056 | ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | Eywa Pharma Inc | ANDA | Current |