Application 019916
- Type
- NDA
- Sponsor
- ICU MEDICAL INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MORPHINE SULFATE | MORPHINE SULFATE | INJECTABLE;INJECTION | 1MG/ML | Yes | Yes |
| 002 | MORPHINE SULFATE | MORPHINE SULFATE | INJECTABLE;INJECTION | 5MG/ML | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019916-001 | MORPHINE SULFATE | MORPHINE SULFATE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-10-30 | |
| N019916-002 | MORPHINE SULFATE | MORPHINE SULFATE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2006-10-27 |
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2026-08 | N019916-001 | MORPHINE SULFATE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-10-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019916-002 | MORPHINE SULFATE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2006-10-27 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N019916-001 | MORPHINE SULFATE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-10-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019916-002 | MORPHINE SULFATE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2006-10-27 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019916-001 | MORPHINE SULFATE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-10-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019916-002 | MORPHINE SULFATE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2006-10-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019916-001 | MORPHINE SULFATE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-10-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019916-002 | MORPHINE SULFATE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2006-10-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019916-001 | MORPHINE SULFATE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-10-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019916-002 | MORPHINE SULFATE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2006-10-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019916-001 | MORPHINE SULFATE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-10-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019916-002 | MORPHINE SULFATE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2006-10-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019916-001 | MORPHINE SULFATE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-10-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019916-002 | MORPHINE SULFATE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2006-10-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019916-001 | MORPHINE SULFATE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-10-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019916-002 | MORPHINE SULFATE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2006-10-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019916-001 | MORPHINE SULFATE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-10-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019916-002 | MORPHINE SULFATE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2006-10-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019916-001 | MORPHINE SULFATE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-10-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019916-002 | MORPHINE SULFATE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2006-10-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019916-001 | MORPHINE SULFATE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-10-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019916-002 | MORPHINE SULFATE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2006-10-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019916-001 | MORPHINE SULFATE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-10-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019916-002 | MORPHINE SULFATE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2006-10-27 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019916-001 | MORPHINE SULFATE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-10-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019916-002 | MORPHINE SULFATE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2006-10-27 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019916-001 | MORPHINE SULFATE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-10-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019916-002 | MORPHINE SULFATE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2006-10-27 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019916-001 | MORPHINE SULFATE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-10-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019916-002 | MORPHINE SULFATE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2006-10-27 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019916-001 | MORPHINE SULFATE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-10-30 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019916-002 | MORPHINE SULFATE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2006-10-27 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019916-001 | MORPHINE SULFATE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-10-30 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019916-002 | MORPHINE SULFATE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2006-10-27 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019916-001 | MORPHINE SULFATE | 1MG/ML | INJECTABLE / INJECTION | RLD | 1992-10-30 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019916-002 | MORPHINE SULFATE | 5MG/ML | INJECTABLE / INJECTION | RLD | 2006-10-27 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019916-001 | MORPHINE SULFATE | 1MG/ML | INJECTABLE / INJECTION | RLD | 1992-10-30 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019916-002 | MORPHINE SULFATE | 5MG/ML | INJECTABLE / INJECTION | RLD | 2006-10-27 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N019916-001 | MORPHINE SULFATE | 1MG/ML | INJECTABLE / INJECTION | AP | RLD, RS | 1992-10-30 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N019916-002 | MORPHINE SULFATE | 5MG/ML | INJECTABLE / INJECTION | RLD | 2006-10-27 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N019916-001 | AP | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | N019916-001 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N019916-001 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N019916-001 | AP | 1 | ea99ee380514… |
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 |
|---|---|---|---|---|---|
| 0409-2029 | Morphine Sulfate | MORPHINE SULFATE | Hospira, Inc. | NDA | Current |
| 0409-2029 | Morphine Sulfate | MORPHINE SULFATE | Hospira, Inc. | NDA | Current |
| 0409-6028 | Morphine Sulfate | MORPHINE SULFATE | Hospira, Inc. | NDA | Current |
| 70518-1107 | Morphine Sulfate | MORPHINE SULFATE | REMEDYREPACK INC. | NDA | Current |
| 70518-1107 | Morphine Sulfate | MORPHINE SULFATE | REMEDYREPACK INC. | NDA | Current |