Application 203849
- Type
- ANDA
- Sponsor
- ACTAVIS ELIZABETH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MORPHINE SULFATE | MORPHINE SULFATE | TABLET, EXTENDED RELEASE;ORAL | 15MG | No | No |
| 002 | MORPHINE SULFATE | MORPHINE SULFATE | TABLET, EXTENDED RELEASE;ORAL | 30MG | No | No |
| 003 | MORPHINE SULFATE | MORPHINE SULFATE | TABLET, EXTENDED RELEASE;ORAL | 60MG | No | No |
| 004 | MORPHINE SULFATE | MORPHINE SULFATE | TABLET, EXTENDED RELEASE;ORAL | 100MG | No | No |
| 005 | MORPHINE SULFATE | MORPHINE SULFATE | TABLET, EXTENDED RELEASE;ORAL | 200MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203849-001 | MORPHINE SULFATE | MORPHINE SULFATE | 15MG | TABLET, EXTENDED RELEASE / ORAL | 2015-04-06 | ||
| A203849-002 | MORPHINE SULFATE | MORPHINE SULFATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2015-04-06 | ||
| A203849-003 | MORPHINE SULFATE | MORPHINE SULFATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | 2015-04-06 | ||
| A203849-004 | MORPHINE SULFATE | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2015-04-06 | ||
| A203849-005 | MORPHINE SULFATE | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2015-04-06 |
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 | A203849-001 | MORPHINE SULFATE | 15MG | TABLET, EXTENDED RELEASE / ORAL | 2015-04-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A203849-002 | MORPHINE SULFATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2015-04-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A203849-003 | MORPHINE SULFATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | 2015-04-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A203849-004 | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 2015-04-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A203849-005 | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2015-04-06 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A203849-001 | MORPHINE SULFATE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203849-002 | MORPHINE SULFATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203849-003 | MORPHINE SULFATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203849-004 | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203849-005 | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203849-001 | MORPHINE SULFATE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203849-002 | MORPHINE SULFATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203849-003 | MORPHINE SULFATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203849-004 | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203849-005 | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203849-001 | MORPHINE SULFATE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203849-002 | MORPHINE SULFATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203849-003 | MORPHINE SULFATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203849-004 | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203849-005 | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203849-001 | MORPHINE SULFATE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203849-002 | MORPHINE SULFATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203849-003 | MORPHINE SULFATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203849-004 | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203849-005 | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203849-001 | MORPHINE SULFATE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203849-002 | MORPHINE SULFATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203849-003 | MORPHINE SULFATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203849-004 | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203849-005 | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203849-001 | MORPHINE SULFATE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203849-002 | MORPHINE SULFATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203849-003 | MORPHINE SULFATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203849-004 | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203849-005 | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203849-001 | MORPHINE SULFATE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203849-002 | MORPHINE SULFATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203849-003 | MORPHINE SULFATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203849-004 | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203849-005 | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-04-06 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A203849-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203849-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203849-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203849-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203849-005 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A203849-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203849-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203849-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203849-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203849-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203849-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203849-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203849-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203849-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203849-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203849-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203849-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203849-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203849-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203849-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203849-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203849-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203849-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203849-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203849-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203849-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203849-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203849-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203849-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203849-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203849-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203849-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203849-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203849-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203849-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203849-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203849-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203849-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203849-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203849-005 | AB | 1 | 2680178bc6a6… |
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 | Bryant Ranch Prepack | fd98b881-5466-457b-b5af-f102aec61546 | 2024-06-05 | Boxed warning, Warnings, Adverse reactions | Morphine sulfate MORPHINE SULFATE |
| Morphine sulfate | MORPHINE SULFATE | Bryant Ranch Prepack | 9a1ca529-8268-4be3-b03f-b2f2238cc9dc | 2024-04-04 | Boxed warning, Warnings, Adverse reactions | Morphine sulfate MORPHINE SULFATE |
| Morphine sulfate | MORPHINE SULFATE | Bryant Ranch Prepack | fb9f929b-8c5a-442b-9695-9d3d45272a5e | 2024-04-04 | Boxed warning, Warnings, Adverse reactions | Morphine sulfate MORPHINE SULFATE |
| Morphine sulfate | MORPHINE SULFATE | Bryant Ranch Prepack | 73a39ce5-b2ab-47b9-8860-796f1d5bc8d8 | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | Morphine sulfate MORPHINE SULFATE |
| Morphine sulfate | MORPHINE SULFATE | Bryant Ranch Prepack | ad08cd86-3825-4e77-bbe8-f6333a9ca9d7 | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | Morphine sulfate MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | Lupin Pharmaceuticals,Inc. | d360a33f-6323-4b10-9e81-07e2813c2dbd | 2024-02-16 | Boxed warning, Warnings, Adverse reactions | Morphine Sulfate MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | Bryant Ranch Prepack | efccad6e-213b-4335-9a4f-3b81322f77c4 | 2024-01-11 | Boxed warning, Warnings, Adverse reactions | Morphine Sulfate MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | Bryant Ranch Prepack | f4f9a7cd-fa6c-41cd-8c4b-04626cfa410a | 2024-01-11 | Boxed warning, Warnings, Adverse reactions | Morphine Sulfate MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | Bryant Ranch Prepack | 72e2071a-43d6-4480-bb84-4984a976618b | 2024-01-11 | Boxed warning, Warnings, Adverse reactions | Morphine Sulfate MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | Bryant Ranch Prepack | 996ac31e-589f-4d5a-84bc-8350e7ea864f | 2024-01-10 | Boxed warning, Warnings, Adverse reactions | Morphine Sulfate MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | Padagis US LLC | 649d731b-962a-45df-b043-7e0781e8a530 | 2023-07-01 | Boxed warning, Warnings, Adverse reactions | Morphine Sulfate MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | Bryant Ranch Prepack | b7b86b6d-9a39-494c-bf65-f62e4cdc5807 | 2023-03-02 | Boxed warning, Warnings, Adverse reactions | Morphine Sulfate MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | Winder Laboratories LLC | e9a7319a-bf1f-48db-a71e-6d4e6ead9555 | 2022-02-28 | Boxed warning, Warnings, Adverse reactions | Morphine Sulfate 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 |
|---|---|---|---|---|---|
| 0228-4270 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4270 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4270 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4270 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4271 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4271 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4271 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4271 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4311 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4311 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4311 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4311 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4323 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4323 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4323 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4323 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4347 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4347 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4347 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4347 | Morphine sulfate | Morphine sulfate | Actavis Pharma, Inc. | ANDA | Current |
| 55700-366 | Morphine sulfate | Morphine sulfate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-366 | Morphine sulfate | Morphine sulfate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-366 | Morphine sulfate | Morphine sulfate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-367 | Morphine sulfate | Morphine sulfate | Lake Erie Medical DBA Qua | ANDA | Current |
| 55700-367 | Morphine sulfate | Morphine sulfate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-368 | Morphine sulfate | Morphine sulfate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-368 | Morphine sulfate | Morphine sulfate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 60760-701 | Morphine sulfate | Morphine sulfate | St Marys Medical Park Pharmacy | ANDA | Current |
| 60760-702 | Morphine sulfate | Morphine sulfate | St Marys Medical Park Pharmacy | ANDA | Current |
| 67296-1375 | Morphine sulfate | Morphine sulfate | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1375 | Morphine sulfate | Morphine sulfate | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1375 | Morphine sulfate | Morphine sulfate | RedPharm Drug, Inc. | ANDA | Current |
| 71335-0239 | Morphine sulfate | Morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0239 | Morphine sulfate | Morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0239 | Morphine sulfate | Morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0605 | Morphine sulfate | Morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0605 | Morphine sulfate | Morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0628 | Morphine sulfate | Morphine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0628 | Morphine sulfate | Morphine sulfate | Bryant Ranch Prepack | ANDA | Current |