Application 208603
- Type
- NDA
- Sponsor
- ZYLA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ARYMO ER | MORPHINE SULFATE | TABLET, EXTENDED RELEASE;ORAL | 15MG | Yes | No |
| 002 | ARYMO ER | MORPHINE SULFATE | TABLET, EXTENDED RELEASE;ORAL | 30MG | Yes | No |
| 003 | ARYMO ER | MORPHINE SULFATE | TABLET, EXTENDED RELEASE;ORAL | 60MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N208603-001 | ARYMO ER | MORPHINE SULFATE | 15MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | |
| N208603-002 | ARYMO ER | MORPHINE SULFATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | |
| N208603-003 | ARYMO ER | MORPHINE SULFATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N208603-001 | 9044402 | 2033-07-01 | U-1556 | Drug product | 2017-02-08 |
| N208603-001 | 9549899 | 2033-07-01 | U-1556 | Drug product | 2017-02-21 |
| N208603-002 | 9044402 | 2033-07-01 | U-1556 | Drug product | 2017-02-08 |
| N208603-002 | 9549899 | 2033-07-01 | U-1556 | Drug product | 2017-02-21 |
| N208603-003 | 9044402 | 2033-07-01 | U-1556 | Drug product | 2017-02-08 |
| N208603-003 | 9549899 | 2033-07-01 | U-1556 | Drug product | 2017-02-21 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N208603-001 | ARYMO ER | 15MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208603-002 | ARYMO ER | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208603-003 | ARYMO ER | 60MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208603-001 | ARYMO ER | 15MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208603-002 | ARYMO ER | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208603-003 | ARYMO ER | 60MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208603-001 | ARYMO ER | 15MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208603-002 | ARYMO ER | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208603-003 | ARYMO ER | 60MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208603-001 | ARYMO ER | 15MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208603-002 | ARYMO ER | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208603-003 | ARYMO ER | 60MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208603-001 | ARYMO ER | 15MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208603-002 | ARYMO ER | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208603-003 | ARYMO ER | 60MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208603-001 | ARYMO ER | 15MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208603-002 | ARYMO ER | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208603-003 | ARYMO ER | 60MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208603-001 | ARYMO ER | 15MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208603-002 | ARYMO ER | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208603-003 | ARYMO ER | 60MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208603-001 | ARYMO ER | 15MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208603-002 | ARYMO ER | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208603-003 | ARYMO ER | 60MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208603-001 | ARYMO ER | 15MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208603-002 | ARYMO ER | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208603-003 | ARYMO ER | 60MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208603-001 | ARYMO ER | 15MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208603-002 | ARYMO ER | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208603-003 | ARYMO ER | 60MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208603-001 | ARYMO ER | 15MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208603-002 | ARYMO ER | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208603-003 | ARYMO ER | 60MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208603-001 | ARYMO ER | 15MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208603-002 | ARYMO ER | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208603-003 | ARYMO ER | 60MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208603-001 | ARYMO ER | 15MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208603-002 | ARYMO ER | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208603-003 | ARYMO ER | 60MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N208603-001 | ARYMO ER | 15MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | 1e350fbaab3a… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N208603-001 | 9044402 | 2033-07-01 | U-1556 | Drug product | 2017-02-08 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N208603-001 | 9549899 | 2033-07-01 | U-1556 | Drug product | 2017-02-21 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N208603-002 | 9044402 | 2033-07-01 | U-1556 | Drug product | 2017-02-08 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N208603-002 | 9549899 | 2033-07-01 | U-1556 | Drug product | 2017-02-21 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N208603-003 | 9044402 | 2033-07-01 | U-1556 | Drug product | 2017-02-08 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N208603-003 | 9549899 | 2033-07-01 | U-1556 | Drug product | 2017-02-21 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N208603-001 | 9044402 | 2033-07-01 | U-1556 | Drug product | 2017-02-08 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208603-001 | 9549899 | 2033-07-01 | U-1556 | Drug product | 2017-02-21 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208603-002 | 9044402 | 2033-07-01 | U-1556 | Drug product | 2017-02-08 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208603-002 | 9549899 | 2033-07-01 | U-1556 | Drug product | 2017-02-21 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208603-003 | 9044402 | 2033-07-01 | U-1556 | Drug product | 2017-02-08 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208603-003 | 9549899 | 2033-07-01 | U-1556 | Drug product | 2017-02-21 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208603-001 | 9044402 | 2033-07-01 | U-1556 | Drug product | 2017-02-08 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208603-001 | 9549899 | 2033-07-01 | U-1556 | Drug product | 2017-02-21 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208603-002 | 9044402 | 2033-07-01 | U-1556 | Drug product | 2017-02-08 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208603-002 | 9549899 | 2033-07-01 | U-1556 | Drug product | 2017-02-21 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208603-003 | 9044402 | 2033-07-01 | U-1556 | Drug product | 2017-02-08 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208603-003 | 9549899 | 2033-07-01 | U-1556 | Drug product | 2017-02-21 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N208603-001 | 9044402 | 2033-07-01 | U-1556 | Drug product | 2017-02-08 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N208603-001 | 9549899 | 2033-07-01 | U-1556 | Drug product | 2017-02-21 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N208603-002 | 9044402 | 2033-07-01 | U-1556 | Drug product | 2017-02-08 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N208603-002 | 9549899 | 2033-07-01 | U-1556 | Drug product | 2017-02-21 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N208603-003 | 9044402 | 2033-07-01 | U-1556 | Drug product | 2017-02-08 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N208603-003 | 9549899 | 2033-07-01 | U-1556 | Drug product | 2017-02-21 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208603-001 | 9044402 | 2033-07-01 | U-1556 | Drug product | 2017-02-08 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208603-001 | 9549899 | 2033-07-01 | U-1556 | Drug product | 2017-02-21 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208603-002 | 9044402 | 2033-07-01 | U-1556 | Drug product | 2017-02-08 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208603-002 | 9549899 | 2033-07-01 | U-1556 | Drug product | 2017-02-21 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208603-003 | 9044402 | 2033-07-01 | U-1556 | Drug product | 2017-02-08 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208603-003 | 9549899 | 2033-07-01 | U-1556 | Drug product | 2017-02-21 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208603-001 | 9044402 | 2033-07-01 | U-1556 | Drug product | 2017-02-08 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208603-001 | 9549899 | 2033-07-01 | U-1556 | Drug product | 2017-02-21 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208603-002 | 9044402 | 2033-07-01 | U-1556 | Drug product | 2017-02-08 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208603-002 | 9549899 | 2033-07-01 | U-1556 | Drug product | 2017-02-21 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208603-003 | 9044402 | 2033-07-01 | U-1556 | Drug product | 2017-02-08 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208603-003 | 9549899 | 2033-07-01 | U-1556 | Drug product | 2017-02-21 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208603-001 | 9044402 | 2033-07-01 | U-1556 | Drug product | 2017-02-08 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208603-001 | 9549899 | 2033-07-01 | U-1556 | Drug product | 2017-02-21 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208603-002 | 9044402 | 2033-07-01 | U-1556 | Drug product | 2017-02-08 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208603-002 | 9549899 | 2033-07-01 | U-1556 | Drug product | 2017-02-21 | 03ed91905a0d… |
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 |
|---|---|---|---|---|---|---|
| Morphine Sulfate | MORPHINE SULFATE | Hikma Pharmaceuticals USA Inc. | 69a0d5be-3211-4b7f-962b-e9d9a507321f | 2026-08-21 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| MS Contin | MORPHINE SULFATE | Rhodes Pharmaceuticals LLC | c354b3bf-86c0-4bb8-8b1f-be2164942698 | 2026-08-14 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | Redpharm Drug | 58476a6b-b54b-5491-e063-6394a90a38c6 | 2026-08-05 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | SpecGx LLC | 8b69f67f-30b3-4982-953e-5a4b87ec6ac6 | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| MORPHINE SULFATE | MORPHINE SULFATE | St. Mary's Medical Park Pharmacy | 57ee014e-744e-65e1-e063-6394a90a8c93 | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | SpecGx LLC | 242c2512-1d49-486b-a9c3-6905f667799e | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine sulfate | MORPHINE SULFATE | Bryant Ranch Prepack | 595243fe-a4b1-479a-99d6-a084a4181891 | 2026-07-13 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | Hikma Pharmaceuticals USA Inc. | 6023606c-150c-40c5-9175-598efe2a56c3 | 2026-07-12 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | Precision Dose, Inc. | 6654b91e-3b3f-4062-ac65-a2a70f942da4 | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate Extended Release | MORPHINE SULFATE | Major Pharmaceuticals | dbb37dfd-0196-45f7-b9ca-393f56cf1d28 | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | Bryant Ranch Prepack | 367d508b-3226-42a9-8dc6-f67cdc9979f3 | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | Precision Dose Inc. | 8d800d8e-8fe2-453b-a8ac-dcf7c47e55fc | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate Extended Release | MORPHINE SULFATE | Rhodes Pharmaceuticals LLC | 19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804 | 2026-05-04 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | American Health Packaging | 5422cdac-8073-41fc-8665-ffe9797f5c02 | 2026-05-01 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | Hospira, Inc. | 1d181906-f3ec-4222-1883-e61577a3122e | 2026-04-21 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate Extended Release | MORPHINE SULFATE | Bryant Ranch Prepack | 2dd52157-3121-41ed-abc2-99b269531e56 | 2026-04-14 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| MORPHINE SULFATE | MORPHINE SULFATE | Bryant Ranch Prepack | d1b0b4ac-69d9-44bf-b7a3-229bd89b9fd6 | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate Extended Release | MORPHINE SULFATE | Bryant Ranch Prepack | c94d9da6-7a12-44ee-a38f-3323ee27842c | 2026-04-03 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate ER | MORPHINE SULFATE | Bryant Ranch Prepack | 872ceecb-1f14-7a43-7451-e4650a01fbd9 | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | Bryant Ranch Prepack | cc3b491c-a206-3027-54f0-f87c0dd40a7f | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69344-111 | Arymo | morphine sulfate | Egalet US Inc. | NDA | Current |
| 69344-111 | Arymo | morphine sulfate | Zyla Life Sciences US Inc. | NDA | Current |
| 69344-211 | Arymo | morphine sulfate | Egalet US Inc. | NDA | Current |
| 69344-211 | Arymo | morphine sulfate | Zyla Life Sciences US Inc. | NDA | Current |
| 69344-311 | Arymo | morphine sulfate | Egalet US Inc. | NDA | Current |
| 69344-311 | Arymo | morphine sulfate | Zyla Life Sciences US Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 60438 | SUPPL | 2019-10-09 |
| 60437 | SUPPL | 2019-10-09 |
| 60367 | SUPPL | 2019-10-08 |
| 55971 | SUPPL | 2018-10-17 |
| 55914 | SUPPL | 2018-10-15 |
| 55726 | SUPPL | 2018-10-01 |
| 55725 | SUPPL | 2018-10-01 |
| 55521 | SUPPL | 2018-09-19 |
| 55520 | SUPPL | 2018-09-19 |
| 48596 | SUPPL | 2017-05-31 |
| 48029 | ORIG | 2017-04-14 |
| 47517 | ORIG | 2017-03-10 |
| 46807 | ORIG | 2017-01-13 |
| 46731 | ORIG | 2017-01-09 |
| 46728 | ORIG | 2017-01-09 |