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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N208603-001 | ARYMO ER | 15MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208603-002 | ARYMO ER | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208603-003 | ARYMO ER | 60MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2017-01-09 | 84e616aacf4f… | |
| 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… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N208603-001 | 9044402 | 2033-07-01 | U-1556 | Drug product | 2017-02-08 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208603-001 | 9549899 | 2033-07-01 | U-1556 | Drug product | 2017-02-21 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208603-002 | 9044402 | 2033-07-01 | U-1556 | Drug product | 2017-02-08 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208603-002 | 9549899 | 2033-07-01 | U-1556 | Drug product | 2017-02-21 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208603-003 | 9044402 | 2033-07-01 | U-1556 | Drug product | 2017-02-08 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208603-003 | 9549899 | 2033-07-01 | U-1556 | Drug product | 2017-02-21 | 84e616aacf4f… |
| 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… |
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 |
|---|---|---|---|---|---|---|
| INFUMORPH 200 | MORPHINE SULFATE | Hikma Pharmaceuticals USA Inc. | db9ac9e3-d761-4a99-9f34-4946ebe8f255 | 2025-12-31 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | Redpharm Drug | 300b6afd-bac8-32ca-e063-6294a90a12a7 | 2025-12-23 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | Upsher-Smith Laboratories, LLC | 5ceb3205-2f8d-4ba3-9f27-dc328bab4fa1 | 2025-12-23 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | American Health Packaging | d66d0cfb-9bfe-490c-90ee-49481c567e85 | 2025-12-05 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | Amneal Pharmaceuticals of New York LLC | f7e9a4b3-a2ee-4f0a-becd-6ef90867332b | 2025-11-28 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | American Health Packaging | 9f1ba2a2-d8ac-4f59-a587-fe413e56dcdb | 2025-11-11 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| MORPHINE SULFATE | MORPHINE SULFATE | Ascend Laboratories, LLC | 07593aa4-f2c4-4d6e-b186-ab2a4ecaa38a | 2025-10-10 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | Nortec Development Associates, Inc. | 9c1a5b8b-8faa-4ee0-80bd-853c239bb1c4 | 2025-08-25 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine sulfate | MORPHINE SULFATE | Bryant Ranch Prepack | 47ea2424-ce2f-4b3b-b393-da1886e7a383 | 2025-07-30 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | Civica, Inc. | 9362eca1-2bc9-4f72-8895-0b9179bfeb2b | 2025-07-15 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | Upsher-Smith Laboratories, LLC | 97948a8f-7d1b-4614-b11d-e944cf56590b | 2025-07-09 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| MORPHINE SULFATE | MORPHINE SULFATE | Bryant Ranch Prepack | 905cd842-2c86-4318-a6c4-92f49de145b3 | 2025-06-16 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate Extended Release | MORPHINE SULFATE | American Health Packaging | f915420d-981d-455b-b4cf-67c8e201a136 | 2024-12-30 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | International Medication Systems, Limited | 1034467f-d436-4b87-a902-c7e8885daa8a | 2024-12-30 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | Bryant Ranch Prepack | 9bb1fef7-4159-4dca-8a8c-37e53ccc6bab | 2024-12-06 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | PAI Holdings, LLC dba PAI Pharma | 6e32b869-31c7-48c1-98ae-b21bd28151d7 | 2024-11-19 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine sulfate | MORPHINE SULFATE | Bryant Ranch Prepack | 2f15f27b-95ed-4cc8-8937-eae07917a6dd | 2024-08-22 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine sulfate | MORPHINE SULFATE | Bryant Ranch Prepack | 20af0f0e-45cc-4795-97ef-90b659575b34 | 2024-08-20 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine sulfate | MORPHINE SULFATE | Bryant Ranch Prepack | 3e310662-16e8-4179-883e-efbca736b14d | 2024-08-05 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine sulfate | MORPHINE SULFATE | Bryant Ranch Prepack | 7f65fa22-c3fc-4413-8a07-2c6be621b7bf | 2024-07-10 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
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 |
|---|---|---|---|---|---|
| 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 |