Application 206308
- Type
- ANDA
- Sponsor
- RHODES PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MORPHINE SULFATE | MORPHINE SULFATE | SOLUTION;ORAL | 10MG/5ML | No | No |
| 002 | MORPHINE SULFATE | MORPHINE SULFATE | SOLUTION;ORAL | 100MG/5ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206308-001 | MORPHINE SULFATE | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | 2017-06-22 | ||
| A206308-002 | MORPHINE SULFATE | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | 2017-06-22 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A206308-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | 2017-06-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206308-002 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | 2017-06-22 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206308-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | 2017-06-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206308-002 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | 2017-06-22 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206308-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | 2017-06-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206308-002 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | 2017-06-22 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206308-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | 2017-06-22 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206308-002 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | 2017-06-22 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206308-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | 2017-06-22 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206308-002 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | 2017-06-22 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206308-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | AA | 2017-06-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206308-002 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | AA | 2017-06-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206308-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | AA | 2017-06-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206308-002 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | AA | 2017-06-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206308-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | AA | 2017-06-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206308-002 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | AA | 2017-06-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206308-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | AA | 2017-06-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206308-002 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | AA | 2017-06-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A206308-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | AA | 2017-06-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A206308-002 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | AA | 2017-06-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206308-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | AA | 2017-06-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206308-002 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | AA | 2017-06-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206308-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | AA | 2017-06-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206308-002 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | AA | 2017-06-22 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206308-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | AA | 2017-06-22 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206308-002 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | AA | 2017-06-22 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A206308-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | AA | 2017-06-22 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A206308-002 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | AA | 2017-06-22 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206308-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | AA | 2017-06-22 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206308-002 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | AA | 2017-06-22 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A206308-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | AA | 2017-06-22 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A206308-002 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | AA | 2017-06-22 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A206308-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | AA | 2017-06-22 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A206308-002 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | AA | 2017-06-22 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A206308-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | AA | 2017-06-22 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A206308-002 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | AA | 2017-06-22 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A206308-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | AA | 2017-06-22 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A206308-002 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | AA | 2017-06-22 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A206308-001 | MORPHINE SULFATE | 10MG/5ML | SOLUTION / ORAL | AA | 2017-06-22 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A206308-002 | MORPHINE SULFATE | 100MG/5ML | SOLUTION / ORAL | AA | 2017-06-22 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206308-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206308-002 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206308-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206308-002 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206308-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206308-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206308-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206308-002 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A206308-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A206308-002 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206308-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206308-002 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206308-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206308-002 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206308-001 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206308-002 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A206308-001 | AA | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A206308-002 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206308-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206308-002 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A206308-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A206308-002 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A206308-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A206308-002 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A206308-001 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A206308-002 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A206308-001 | AA | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A206308-002 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A206308-001 | AA | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A206308-002 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206308-001 | AA | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206308-002 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A206308-001 | AA | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A206308-002 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A206308-001 | AA | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A206308-002 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A206308-001 | AA | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A206308-002 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A206308-001 | AA | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A206308-002 | AA | 1 | 3f01610625f2… |
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 | MORPHINE SULFATE | SpecGx LLC | 8b69f67f-30b3-4982-953e-5a4b87ec6ac6 | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | Morphine Sulfate 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 | MORPHINE SULFATE | SpecGx LLC | 242c2512-1d49-486b-a9c3-6905f667799e | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | Morphine Sulfate 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 | MORPHINE SULFATE | Hikma Pharmaceuticals USA Inc. | 6023606c-150c-40c5-9175-598efe2a56c3 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | Morphine Sulfate 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 | MORPHINE SULFATE | Precision Dose, Inc. | bb6b3439-9f0c-45f5-bf6f-c7a971af0a8f | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | Morphine Sulfate 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 | MORPHINE SULFATE | Precision Dose, Inc. | 67f0ee8d-696e-4c08-9007-3df0e3988bad | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | Morphine Sulfate 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 | MORPHINE SULFATE | Precision Dose Inc. | 8d800d8e-8fe2-453b-a8ac-dcf7c47e55fc | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | Morphine Sulfate 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 | Hospira, Inc. | 1d181906-f3ec-4222-1883-e61577a3122e | 2026-04-21 | Boxed warning, Warnings, Adverse reactions | Morphine Sulfate 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 |
| 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 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42858-810 | Morphine Sulfate | Morphine Sulfate | Rhodes Pharmaceuticals L.P. | ANDA | Current |
| 42858-810 | Morphine Sulfate | Morphine Sulfate | Rhodes Pharmaceuticals L.P. | ANDA | Current |
| 42858-810 | Morphine Sulfate | Morphine Sulfate | Rhodes Pharmaceuticals L.P. | ANDA | Current |
| 42858-812 | Morphine Sulfate | Morphine Sulfate | Rhodes Pharmaceuticals L.P. | ANDA | Current |
| 42858-812 | Morphine Sulfate | Morphine Sulfate | Rhodes Pharmaceuticals L.P. | ANDA | Current |
| 42858-812 | Morphine Sulfate | Morphine Sulfate | Rhodes Pharmaceuticals L.P. | ANDA | Current |