Application 204223

Type: NDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MORPHINE SULFATE	MORPHINE SULFATE	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	2MG/ML (2MG/ML)	Yes	Yes
002	MORPHINE SULFATE	MORPHINE SULFATE	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	4MG/ML (4MG/ML)	Yes	Yes
003	MORPHINE SULFATE	MORPHINE SULFATE	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	5MG/ML (5MG/ML)	Yes	Yes
004	MORPHINE SULFATE	MORPHINE SULFATE	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	8MG/ML (8MG/ML)	Yes	Yes
005	MORPHINE SULFATE	MORPHINE SULFATE	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	10MG/ML (10MG/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N204223-001	MORPHINE SULFATE	MORPHINE SULFATE	2MG/ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30
N204223-002	MORPHINE SULFATE	MORPHINE SULFATE	4MG/ML (4MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30
N204223-003	MORPHINE SULFATE	MORPHINE SULFATE	5MG/ML (5MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD	2013-10-30
N204223-004	MORPHINE SULFATE	MORPHINE SULFATE	8MG/ML (8MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD	2013-10-30
N204223-005	MORPHINE SULFATE	MORPHINE SULFATE	10MG/ML (10MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30
N204223-006	MORPHINE SULFATE	MORPHINE SULFATE	1MG/0.5ML (1MG/0.5ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD	2026-05-29

Orange Book patents#

Current patent rows page 1 of 1 · 20 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204223-001	9072781	2034-03-12		Drug product	2015-07-13
N204223-001	9192608	2034-03-12	U-43		2015-12-04
N204223-001	9192608	2034-03-12	U-55		2015-12-04
N204223-001	9248229	2034-03-12		Drug product	2016-02-17
N204223-002	9072781	2034-03-12		Drug product	2015-07-13
N204223-002	9192608	2034-03-12	U-43		2015-12-04
N204223-002	9192608	2034-03-12	U-55		2015-12-04
N204223-002	9248229	2034-03-12		Drug product	2016-02-17
N204223-003	9072781	2034-03-12		Drug product	2015-07-13
N204223-003	9192608	2034-03-12	U-43		2015-12-04
N204223-003	9192608	2034-03-12	U-55		2015-12-04
N204223-003	9248229	2034-03-12		Drug product	2016-02-17
N204223-004	9072781	2034-03-12		Drug product	2015-07-13
N204223-004	9192608	2034-03-12	U-43		2015-12-04
N204223-004	9192608	2034-03-12	U-55		2015-12-04
N204223-004	9248229	2034-03-12		Drug product	2016-02-17
N204223-005	9072781	2034-03-12		Drug product	2015-07-13
N204223-005	9192608	2034-03-12	U-43		2015-12-04
N204223-005	9192608	2034-03-12	U-55		2015-12-04
N204223-005	9248229	2034-03-12		Drug product	2016-02-17

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.

Product history page 2 of 6 · 221 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204223-005	MORPHINE SULFATE	10MG/ML (10MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204223-001	MORPHINE SULFATE	2MG/ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204223-002	MORPHINE SULFATE	4MG/ML (4MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204223-003	MORPHINE SULFATE	5MG/ML (5MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD	2013-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204223-004	MORPHINE SULFATE	8MG/ML (8MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD	2013-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204223-005	MORPHINE SULFATE	10MG/ML (10MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204223-001	MORPHINE SULFATE	2MG/ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204223-002	MORPHINE SULFATE	4MG/ML (4MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204223-003	MORPHINE SULFATE	5MG/ML (5MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD	2013-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204223-004	MORPHINE SULFATE	8MG/ML (8MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD	2013-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204223-005	MORPHINE SULFATE	10MG/ML (10MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204223-001	MORPHINE SULFATE	2MG/ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204223-002	MORPHINE SULFATE	4MG/ML (4MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204223-003	MORPHINE SULFATE	5MG/ML (5MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204223-004	MORPHINE SULFATE	8MG/ML (8MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204223-005	MORPHINE SULFATE	10MG/ML (10MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204223-001	MORPHINE SULFATE	2MG/ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204223-002	MORPHINE SULFATE	4MG/ML (4MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204223-003	MORPHINE SULFATE	5MG/ML (5MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD	2013-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204223-004	MORPHINE SULFATE	8MG/ML (8MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD	2013-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204223-005	MORPHINE SULFATE	10MG/ML (10MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204223-001	MORPHINE SULFATE	2MG/ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204223-002	MORPHINE SULFATE	4MG/ML (4MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204223-003	MORPHINE SULFATE	5MG/ML (5MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD	2013-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204223-004	MORPHINE SULFATE	8MG/ML (8MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD	2013-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204223-005	MORPHINE SULFATE	10MG/ML (10MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204223-001	MORPHINE SULFATE	2MG/ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204223-002	MORPHINE SULFATE	4MG/ML (4MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204223-003	MORPHINE SULFATE	5MG/ML (5MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204223-004	MORPHINE SULFATE	8MG/ML (8MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204223-005	MORPHINE SULFATE	10MG/ML (10MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204223-001	MORPHINE SULFATE	2MG/ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204223-002	MORPHINE SULFATE	4MG/ML (4MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204223-003	MORPHINE SULFATE	5MG/ML (5MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204223-004	MORPHINE SULFATE	8MG/ML (8MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204223-005	MORPHINE SULFATE	10MG/ML (10MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204223-001	MORPHINE SULFATE	2MG/ML (2MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204223-002	MORPHINE SULFATE	4MG/ML (4MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204223-003	MORPHINE SULFATE	5MG/ML (5MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204223-004	MORPHINE SULFATE	8MG/ML (8MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2013-10-30	`1e350fbaab3a…`

Observed Orange Book patent history#

Patent history page 1 of 22 · 880 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N204223-001	9072781	2034-03-12		Drug product	2015-07-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204223-001	9192608	2034-03-12	U-43		2015-12-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204223-001	9192608	2034-03-12	U-55		2015-12-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204223-001	9248229	2034-03-12		Drug product	2016-02-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204223-002	9072781	2034-03-12		Drug product	2015-07-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204223-002	9192608	2034-03-12	U-43		2015-12-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204223-002	9192608	2034-03-12	U-55		2015-12-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204223-002	9248229	2034-03-12		Drug product	2016-02-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204223-003	9072781	2034-03-12		Drug product	2015-07-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204223-003	9192608	2034-03-12	U-55		2015-12-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204223-003	9192608	2034-03-12	U-43		2015-12-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204223-003	9248229	2034-03-12		Drug product	2016-02-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204223-004	9072781	2034-03-12		Drug product	2015-07-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204223-004	9192608	2034-03-12	U-43		2015-12-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204223-004	9192608	2034-03-12	U-55		2015-12-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204223-004	9248229	2034-03-12		Drug product	2016-02-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204223-005	9072781	2034-03-12		Drug product	2015-07-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204223-005	9192608	2034-03-12	U-55		2015-12-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204223-005	9192608	2034-03-12	U-43		2015-12-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204223-005	9248229	2034-03-12		Drug product	2016-02-17	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N204223-001	9072781	2034-03-12		Drug product	2015-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-001	9192608	2034-03-12	U-43		2015-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-001	9192608	2034-03-12	U-55		2015-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-001	9248229	2034-03-12		Drug product	2016-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-002	9072781	2034-03-12		Drug product	2015-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-002	9192608	2034-03-12	U-43		2015-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-002	9192608	2034-03-12	U-55		2015-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-002	9248229	2034-03-12		Drug product	2016-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-003	9072781	2034-03-12		Drug product	2015-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-003	9192608	2034-03-12	U-55		2015-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-003	9192608	2034-03-12	U-43		2015-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-003	9248229	2034-03-12		Drug product	2016-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-004	9072781	2034-03-12		Drug product	2015-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-004	9192608	2034-03-12	U-43		2015-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-004	9192608	2034-03-12	U-55		2015-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-004	9248229	2034-03-12		Drug product	2016-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-005	9072781	2034-03-12		Drug product	2015-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-005	9192608	2034-03-12	U-55		2015-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-005	9192608	2034-03-12	U-43		2015-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204223-005	9248229	2034-03-12		Drug product	2016-02-17	`84e616aacf4f…`

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.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Morphine Sulfate	MORPHINE SULFATE	Fresenius Kabi, USA LLC	1f53de80-efc8-4930-b3e3-fba0d026af05	2026-08-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204223 application number: NDA204223 ndc (product): 76045-008 ndc (product): 76045-004 ndc (product): 76045-005 ndc (product): 76045-006 ndc (product): 76045-007
Morphine Sulfate	MORPHINE SULFATE	Fresenius Kabi USA, LLC	582f42e5-444e-4246-af8c-e7e28097c69a	2026-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204223 application number: NDA204223 ndc (product): 63323-452 ndc (product): 63323-454 ndc (product): 63323-458 ndc (product): 63323-451 ndc (product): 63323-455

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 55 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63323-451	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
63323-451	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
63323-451	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
63323-452	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
63323-452	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
63323-452	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
63323-454	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
63323-454	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
63323-454	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
63323-455	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
63323-455	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
63323-455	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
63323-458	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
63323-458	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
63323-458	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
76045-004	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
76045-004	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi, USA LLC	NDA	Current
76045-004	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
76045-004	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
76045-004	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
76045-004	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
76045-004	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi, USA LLC	NDA	Current
76045-004	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi, USA LLC	NDA	Current
76045-005	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
76045-005	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi, USA LLC	NDA	Current
76045-005	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
76045-005	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
76045-005	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
76045-005	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
76045-005	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi, USA LLC	NDA	Current
76045-005	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi, USA LLC	NDA	Current
76045-006	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
76045-006	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi, USA LLC	NDA	Current
76045-006	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
76045-006	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
76045-006	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
76045-006	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
76045-006	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi, USA LLC	NDA	Current
76045-006	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi, USA LLC	NDA	Current
76045-007	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
76045-007	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi, USA LLC	NDA	Current
76045-007	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
76045-007	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
76045-007	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
76045-007	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
76045-007	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi, USA LLC	NDA	Current
76045-007	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi, USA LLC	NDA	Current
76045-008	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
76045-008	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi, USA LLC	NDA	Current
76045-008	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
76045-008	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
76045-008	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
76045-008	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi USA, LLC	NDA	Current
76045-008	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi, USA LLC	NDA	Current
76045-008	Morphine Sulfate	Morphine Sulfate	Fresenius Kabi, USA LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84657	SUPPL	2026-01-06
84576	SUPPL	2025-12-29
77056	SUPPL	2023-12-19
76957	SUPPL	2023-12-18
60502	SUPPL	2019-10-09
60459	SUPPL	2019-10-09
46438	SUPPL	2016-12-21
46432	SUPPL	2016-12-21
24462	ORIG	2014-03-06
22947	ORIG	2014-03-06
10307	ORIG	2013-11-06
19534	ORIG	2013-10-31