Application 020616
- Type
- NDA
- Sponsor
- ALLERGAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | KADIAN | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 20MG | Yes | No |
| 002 | KADIAN | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 50MG | Yes | No |
| 003 | KADIAN | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 100MG | Yes | Yes |
| 004 | KADIAN | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 30MG | Yes | No |
| 005 | KADIAN | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 60MG | Yes | No |
| 006 | KADIAN | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 80MG | Yes | No |
| 007 | KADIAN | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 200MG | Yes | Yes |
| 008 | KADIAN | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 10MG | Yes | Yes |
| 009 | KADIAN | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 40MG | Yes | No |
| 010 | KADIAN | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 70MG | Yes | No |
| 011 | KADIAN | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 130MG | Yes | No |
| 012 | KADIAN | MORPHINE SULFATE | CAPSULE, EXTENDED RELEASE;ORAL | 150MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020616-001 | KADIAN | MORPHINE SULFATE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1996-07-03 | |
| N020616-002 | KADIAN | MORPHINE SULFATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1996-07-03 | |
| N020616-003 | KADIAN | MORPHINE SULFATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1996-07-03 | |
| N020616-004 | KADIAN | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2001-03-09 | |
| N020616-005 | KADIAN | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2001-03-09 | |
| N020616-006 | KADIAN | MORPHINE SULFATE | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2006-10-27 | |
| N020616-007 | KADIAN | MORPHINE SULFATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2007-02-27 | |
| N020616-008 | KADIAN | MORPHINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2007-04-20 | |
| N020616-009 | KADIAN | MORPHINE SULFATE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2012-07-09 | |
| N020616-010 | KADIAN | MORPHINE SULFATE | 70MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2012-07-09 | |
| N020616-011 | KADIAN | MORPHINE SULFATE | 130MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2012-07-09 | |
| N020616-012 | KADIAN | MORPHINE SULFATE | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2012-07-09 |
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 | N020616-001 | KADIAN | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1996-07-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020616-002 | KADIAN | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1996-07-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020616-003 | KADIAN | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1996-07-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020616-004 | KADIAN | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2001-03-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020616-005 | KADIAN | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2001-03-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020616-006 | KADIAN | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2006-10-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020616-007 | KADIAN | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2007-02-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020616-008 | KADIAN | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2007-04-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020616-009 | KADIAN | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2012-07-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020616-010 | KADIAN | 70MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2012-07-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020616-011 | KADIAN | 130MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2012-07-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020616-012 | KADIAN | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2012-07-09 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020616-001 | KADIAN | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1996-07-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020616-002 | KADIAN | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1996-07-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020616-003 | KADIAN | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1996-07-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020616-004 | KADIAN | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2001-03-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020616-005 | KADIAN | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2001-03-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020616-006 | KADIAN | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2006-10-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020616-007 | KADIAN | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2007-02-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020616-008 | KADIAN | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2007-04-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020616-009 | KADIAN | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2012-07-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020616-010 | KADIAN | 70MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2012-07-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020616-011 | KADIAN | 130MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2012-07-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020616-012 | KADIAN | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2012-07-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020616-001 | KADIAN | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1996-07-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020616-002 | KADIAN | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1996-07-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020616-003 | KADIAN | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1996-07-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020616-004 | KADIAN | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2001-03-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020616-005 | KADIAN | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2001-03-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020616-006 | KADIAN | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2006-10-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020616-007 | KADIAN | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2007-02-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020616-008 | KADIAN | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2007-04-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020616-009 | KADIAN | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2012-07-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020616-010 | KADIAN | 70MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2012-07-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020616-011 | KADIAN | 130MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2012-07-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020616-012 | KADIAN | 150MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2012-07-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020616-001 | KADIAN | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1996-07-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020616-002 | KADIAN | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1996-07-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020616-003 | KADIAN | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1996-07-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020616-004 | KADIAN | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2001-03-09 | 6a471c1ec25d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N020616-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020616-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020616-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020616-004 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020616-005 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020616-006 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020616-008 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020616-009 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020616-010 | AB | 1 | 74a2ff9319b5… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020616-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020616-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020616-003 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020616-004 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020616-005 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020616-006 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020616-008 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020616-009 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N020616-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N020616-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N020616-003 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N020616-004 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N020616-005 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N020616-006 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N020616-008 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N020616-009 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N020616-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N020616-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N020616-003 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N020616-004 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N020616-005 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N020616-006 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N020616-008 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N020616-009 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N020616-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N020616-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N020616-003 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N020616-004 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N020616-005 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N020616-006 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N020616-008 | AB | 1 | c0c555d07b60… |
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 | 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 | Hikma Pharmaceuticals USA Inc. | 69a0d5be-3211-4b7f-962b-e9d9a507321f | 2026-07-03 | 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 | MORPHINE SULFATE | Precision Dose, Inc. | bb6b3439-9f0c-45f5-bf6f-c7a971af0a8f | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | Precision Dose, Inc. | 76966c05-df75-4072-ae99-97e42f91ab75 | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | Precision Dose, Inc. | 67f0ee8d-696e-4c08-9007-3df0e3988bad | 2026-06-09 | 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 |
| MS Contin | MORPHINE SULFATE | Rhodes Pharmaceuticals LLC | c354b3bf-86c0-4bb8-8b1f-be2164942698 | 2026-05-18 | 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 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0023-6011 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6011 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6011 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6011 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6011 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6011 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6012 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6012 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6012 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6012 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6012 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6012 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6013 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6013 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6013 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6013 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6013 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6013 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6014 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6014 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6014 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6014 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6014 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6015 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6015 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6015 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6015 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6015 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6015 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6016 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6016 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6016 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6016 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6016 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6016 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6017 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6017 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6017 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6017 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6017 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6017 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6018 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6018 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6018 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6018 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6018 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6018 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6019 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6019 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6019 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6019 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6019 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0023-6019 | Kadian | morphine sulfate | Allergan, Inc. | NDA | Current |
| 0228-3501 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3501 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3501 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3501 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3501 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3501 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3501 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3502 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3502 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3502 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3502 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3502 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3502 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3502 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3503 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3503 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3503 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3503 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3503 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3503 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3503 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3504 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3504 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3504 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3504 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3504 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0228-3504 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 66587 | SUPPL | 2021-03-08 |
| 66586 | SUPPL | 2021-03-08 |
| 66505 | SUPPL | 2021-03-05 |
| 60343 | SUPPL | 2019-10-08 |
| 60329 | SUPPL | 2019-10-08 |
| 60328 | SUPPL | 2019-10-08 |
| 55901 | SUPPL | 2018-10-12 |
| 55900 | SUPPL | 2018-10-12 |
| 55661 | SUPPL | 2018-09-28 |
| 55660 | SUPPL | 2018-09-28 |
| 48568 | SUPPL | 2017-05-30 |
| 46383 | SUPPL | 2016-12-21 |
| 46253 | SUPPL | 2016-12-20 |
| 45462 | SUPPL | 2016-10-04 |
| 2888 | SUPPL | 2016-04-22 |
| 2887 | SUPPL | 2015-07-02 |
| 2886 | SUPPL | 2014-08-20 |
| 2885 | SUPPL | 2014-04-17 |
| 34964 | SUPPL | 2014-04-16 |
| 25330 | SUPPL | 2013-04-17 |
| 2884 | SUPPL | 2013-03-29 |
| 34963 | SUPPL | 2012-07-13 |
| 34962 | SUPPL | 2012-07-12 |
| 44453 | ORIG | 2012-07-11 |
| 25329 | SUPPL | 2012-07-11 |
| 20768 | SUPPL | 2011-02-04 |
| 41484 | SUPPL | 2007-11-19 |
| 41483 | SUPPL | 2007-11-19 |
| 25328 | SUPPL | 2007-05-01 |
| 12854 | SUPPL | 2007-04-25 |
| 34960 | SUPPL | 2007-03-07 |
| 25327 | SUPPL | 2007-03-07 |
| 12853 | SUPPL | 2007-03-07 |
| 2882 | SUPPL | 2007-03-07 |
| 34961 | SUPPL | 2006-11-06 |
| 2883 | SUPPL | 2006-11-06 |
| 25326 | SUPPL | 2005-10-20 |
| 12852 | SUPPL | 2005-09-30 |