Application 022321
- Type
- NDA
- Sponsor
- ALPHARMA PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EMBEDA | MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 20MG;0.8MG | Yes | No |
| 002 | EMBEDA | MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 30MG;1.2MG | Yes | No |
| 003 | EMBEDA | MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 50MG;2MG | Yes | No |
| 004 | EMBEDA | MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 60MG;2.4MG | Yes | No |
| 005 | EMBEDA | MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 80MG;3.2MG | Yes | No |
| 006 | EMBEDA | MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 100MG;4MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022321-001 | EMBEDA | MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE | 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | |
| N022321-002 | EMBEDA | MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE | 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | |
| N022321-003 | EMBEDA | MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE | 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | |
| N022321-004 | EMBEDA | MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE | 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | |
| N022321-005 | EMBEDA | MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE | 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | |
| N022321-006 | EMBEDA | MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE | 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022321-001 | 7682633 | 2027-06-19 | U-1510 | ||
| N022321-001 | 7682634 | 2027-06-19 | Drug product | ||
| N022321-001 | 8158156 | 2027-06-19 | U-1510 | 2012-05-10 | |
| N022321-001 | 8846104 | 2027-06-19 | Drug product | 2014-10-28 | |
| N022321-001 | 8877247 | 2027-06-19 | Drug product | 2014-12-01 | |
| N022321-001 | 7815934 | 2027-12-12 | Drug product | 2010-10-19 | |
| N022321-001 | 8623418 | 2029-11-07 | U-1640 | 2015-01-22 | |
| N022321-002 | 7682633 | 2027-06-19 | U-1510 | ||
| N022321-002 | 7682634 | 2027-06-19 | Drug product | ||
| N022321-002 | 8158156 | 2027-06-19 | U-1510 | ||
| N022321-002 | 8846104 | 2027-06-19 | Drug product | 2014-10-28 | |
| N022321-002 | 8877247 | 2027-06-19 | Drug product | 2014-12-01 | |
| N022321-002 | 7815934 | 2027-12-12 | Drug product | ||
| N022321-002 | 8623418 | 2029-11-07 | U-1640 | 2015-01-22 | |
| N022321-003 | 7682633 | 2027-06-19 | U-1510 | ||
| N022321-003 | 7682634 | 2027-06-19 | Drug product | ||
| N022321-003 | 8158156 | 2027-06-19 | U-1510 | ||
| N022321-003 | 8846104 | 2027-06-19 | Drug product | 2014-10-28 | |
| N022321-003 | 8877247 | 2027-06-19 | Drug product | 2014-12-01 | |
| N022321-003 | 7815934 | 2027-12-12 | Drug product | ||
| N022321-003 | 8623418 | 2029-11-07 | U-1640 | 2015-01-22 | |
| N022321-004 | 7682633 | 2027-06-19 | U-1510 | ||
| N022321-004 | 7682634 | 2027-06-19 | Drug product | ||
| N022321-004 | 8158156 | 2027-06-19 | U-1510 | ||
| N022321-004 | 8846104 | 2027-06-19 | Drug product | 2014-10-28 | |
| N022321-004 | 8877247 | 2027-06-19 | Drug product | 2014-12-01 | |
| N022321-004 | 7815934 | 2027-12-12 | Drug product | ||
| N022321-004 | 8623418 | 2029-11-07 | U-1640 | 2015-01-22 | |
| N022321-005 | 7682633 | 2027-06-19 | U-1510 | ||
| N022321-005 | 7682634 | 2027-06-19 | Drug product | ||
| N022321-005 | 8158156 | 2027-06-19 | U-1510 | ||
| N022321-005 | 8846104 | 2027-06-19 | Drug product | 2014-10-28 | |
| N022321-005 | 8877247 | 2027-06-19 | Drug product | 2014-12-01 | |
| N022321-005 | 7815934 | 2027-12-12 | Drug product | ||
| N022321-005 | 8623418 | 2029-11-07 | U-1640 | 2015-01-22 | |
| N022321-006 | 7682633 | 2027-06-19 | U-1510 | ||
| N022321-006 | 7682634 | 2027-06-19 | Drug product | ||
| N022321-006 | 8158156 | 2027-06-19 | U-1510 | ||
| N022321-006 | 8846104 | 2027-06-19 | Drug product | 2014-10-28 | |
| N022321-006 | 8877247 | 2027-06-19 | Drug product | 2014-12-01 | |
| N022321-006 | 7815934 | 2027-12-12 | Drug product | ||
| N022321-006 | 8623418 | 2029-11-07 | U-1640 | 2015-01-22 |
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 | N022321-001 | EMBEDA | 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-002 | EMBEDA | 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-003 | EMBEDA | 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-004 | EMBEDA | 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-005 | EMBEDA | 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-006 | EMBEDA | 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N022321-001 | EMBEDA | 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022321-002 | EMBEDA | 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022321-003 | EMBEDA | 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022321-004 | EMBEDA | 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022321-005 | EMBEDA | 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022321-006 | EMBEDA | 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022321-001 | EMBEDA | 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022321-002 | EMBEDA | 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022321-003 | EMBEDA | 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022321-004 | EMBEDA | 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022321-005 | EMBEDA | 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022321-006 | EMBEDA | 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022321-001 | EMBEDA | 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022321-002 | EMBEDA | 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022321-003 | EMBEDA | 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022321-004 | EMBEDA | 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022321-005 | EMBEDA | 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022321-006 | EMBEDA | 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022321-001 | EMBEDA | 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022321-002 | EMBEDA | 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022321-003 | EMBEDA | 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022321-004 | EMBEDA | 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022321-005 | EMBEDA | 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022321-006 | EMBEDA | 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022321-001 | EMBEDA | 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022321-002 | EMBEDA | 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022321-003 | EMBEDA | 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022321-004 | EMBEDA | 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022321-005 | EMBEDA | 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022321-006 | EMBEDA | 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022321-001 | EMBEDA | 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022321-002 | EMBEDA | 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022321-003 | EMBEDA | 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022321-004 | EMBEDA | 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | b8a1b40f171c… |
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 | N022321-001 | 7682633 | 2027-06-19 | U-1510 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-001 | 7682634 | 2027-06-19 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-001 | 8158156 | 2027-06-19 | U-1510 | 2012-05-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-001 | 8846104 | 2027-06-19 | Drug product | 2014-10-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-001 | 8877247 | 2027-06-19 | Drug product | 2014-12-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-001 | 7815934 | 2027-12-12 | Drug product | 2010-10-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-001 | 8623418 | 2029-11-07 | U-1640 | 2015-01-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-002 | 7682633 | 2027-06-19 | U-1510 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-002 | 7682634 | 2027-06-19 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-002 | 8158156 | 2027-06-19 | U-1510 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-002 | 8846104 | 2027-06-19 | Drug product | 2014-10-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-002 | 8877247 | 2027-06-19 | Drug product | 2014-12-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-002 | 7815934 | 2027-12-12 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-002 | 8623418 | 2029-11-07 | U-1640 | 2015-01-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-003 | 7682633 | 2027-06-19 | U-1510 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-003 | 7682634 | 2027-06-19 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-003 | 8158156 | 2027-06-19 | U-1510 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-003 | 8846104 | 2027-06-19 | Drug product | 2014-10-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-003 | 8877247 | 2027-06-19 | Drug product | 2014-12-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-003 | 7815934 | 2027-12-12 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-003 | 8623418 | 2029-11-07 | U-1640 | 2015-01-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-004 | 7682633 | 2027-06-19 | U-1510 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-004 | 7682634 | 2027-06-19 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-004 | 8158156 | 2027-06-19 | U-1510 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-004 | 8846104 | 2027-06-19 | Drug product | 2014-10-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-004 | 8877247 | 2027-06-19 | Drug product | 2014-12-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-004 | 7815934 | 2027-12-12 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-004 | 8623418 | 2029-11-07 | U-1640 | 2015-01-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-005 | 7682633 | 2027-06-19 | U-1510 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-005 | 7682634 | 2027-06-19 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-005 | 8158156 | 2027-06-19 | U-1510 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-005 | 8846104 | 2027-06-19 | Drug product | 2014-10-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-005 | 8877247 | 2027-06-19 | Drug product | 2014-12-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-005 | 7815934 | 2027-12-12 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-005 | 8623418 | 2029-11-07 | U-1640 | 2015-01-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-006 | 7682633 | 2027-06-19 | U-1510 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-006 | 7682634 | 2027-06-19 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-006 | 8158156 | 2027-06-19 | U-1510 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-006 | 8846104 | 2027-06-19 | Drug product | 2014-10-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-006 | 8877247 | 2027-06-19 | Drug product | 2014-12-01 | 84e616aacf4f… |
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 |
|---|---|---|---|---|---|
| 60793-430 | EMBEDA | MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 60793-430 | EMBEDA | MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 60793-431 | EMBEDA | MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 60793-431 | EMBEDA | MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 60793-433 | EMBEDA | MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 60793-433 | EMBEDA | MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 60793-434 | EMBEDA | MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 60793-434 | EMBEDA | MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 60793-435 | EMBEDA | MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 60793-435 | EMBEDA | MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 60793-437 | EMBEDA | MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 60793-437 | EMBEDA | MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 60386 | SUPPL | 2019-10-08 |
| 60385 | SUPPL | 2019-10-08 |
| 60366 | SUPPL | 2019-10-08 |
| 55689 | SUPPL | 2018-10-01 |
| 55688 | SUPPL | 2018-10-01 |
| 55637 | SUPPL | 2018-09-27 |
| 55636 | SUPPL | 2018-09-27 |
| 55635 | SUPPL | 2018-09-27 |
| 55634 | SUPPL | 2018-09-27 |
| 48582 | SUPPL | 2017-05-31 |
| 46339 | SUPPL | 2016-12-21 |
| 46332 | SUPPL | 2016-12-21 |
| 45467 | SUPPL | 2016-10-04 |
| 29594 | SUPPL | 2016-04-22 |
| 44495 | ORIG | 2015-11-04 |
| 29593 | SUPPL | 2015-07-06 |
| 43556 | SUPPL | 2014-10-17 |
| 29592 | SUPPL | 2014-10-17 |
| 17240 | SUPPL | 2014-10-17 |
| 7235 | SUPPL | 2014-08-20 |
| 7234 | SUPPL | 2014-04-17 |
| 17241 | SUPPL | 2014-04-16 |
| 17239 | SUPPL | 2013-11-05 |
| 29591 | SUPPL | 2013-06-04 |
| 17238 | SUPPL | 2013-06-03 |
| 7233 | SUPPL | 2013-04-18 |
| 17237 | SUPPL | 2012-07-12 |
| 44496 | ORIG | 2012-07-11 |
| 29590 | SUPPL | 2012-07-11 |
| 42492 | ORIG | 2010-05-25 |
| 7232 | ORIG | 2009-08-19 |
| 38573 | ORIG | 2009-08-18 |