Application 202515

Type: NDA
Sponsor: HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MORPHINE SULFATE	MORPHINE SULFATE	INJECTABLE;INJECTION	2MG/ML	Yes	Yes
002	MORPHINE SULFATE	MORPHINE SULFATE	INJECTABLE;INJECTION	4MG/ML	Yes	Yes
003	MORPHINE SULFATE	MORPHINE SULFATE	INJECTABLE;INJECTION	8MG/ML	Yes	Yes
004	MORPHINE SULFATE	MORPHINE SULFATE	INJECTABLE;INJECTION	10MG/ML	Yes	Yes
005	MORPHINE SULFATE	MORPHINE SULFATE	INJECTABLE;INJECTION	15MG/ML	Yes	No
006	MORPHINE SULFATE	MORPHINE SULFATE	INJECTABLE;INJECTION	50MG/ML	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	TE codes	RLD / RS	Approval date
N202515-001	MORPHINE SULFATE	MORPHINE SULFATE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2011-11-14
N202515-002	MORPHINE SULFATE	MORPHINE SULFATE	4MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-11-14
N202515-003	MORPHINE SULFATE	MORPHINE SULFATE	8MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-11-14
N202515-004	MORPHINE SULFATE	MORPHINE SULFATE	10MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-11-14
N202515-005	MORPHINE SULFATE	MORPHINE SULFATE	15MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2011-11-14
N202515-006	MORPHINE SULFATE	MORPHINE SULFATE	50MG/ML	INJECTABLE / INJECTION		RLD, RS	2021-04-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N202515-001	AP
N202515-002	AP
N202515-003	AP
N202515-004	AP

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 1 of 7 · 244 observed states.

Captured, Edition, Application-product table
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	N202515-001	MORPHINE SULFATE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2011-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202515-002	MORPHINE SULFATE	4MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202515-003	MORPHINE SULFATE	8MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202515-004	MORPHINE SULFATE	10MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202515-005	MORPHINE SULFATE	15MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2011-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202515-006	MORPHINE SULFATE	50MG/ML	INJECTABLE / INJECTION		RLD, RS	2021-04-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202515-001	MORPHINE SULFATE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2011-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202515-002	MORPHINE SULFATE	4MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202515-003	MORPHINE SULFATE	8MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202515-004	MORPHINE SULFATE	10MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202515-005	MORPHINE SULFATE	15MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2011-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202515-006	MORPHINE SULFATE	50MG/ML	INJECTABLE / INJECTION		RLD, RS	2021-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202515-001	MORPHINE SULFATE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2011-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202515-002	MORPHINE SULFATE	4MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202515-003	MORPHINE SULFATE	8MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202515-004	MORPHINE SULFATE	10MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202515-005	MORPHINE SULFATE	15MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2011-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202515-006	MORPHINE SULFATE	50MG/ML	INJECTABLE / INJECTION		RLD, RS	2021-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202515-001	MORPHINE SULFATE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2011-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202515-002	MORPHINE SULFATE	4MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202515-003	MORPHINE SULFATE	8MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202515-004	MORPHINE SULFATE	10MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202515-005	MORPHINE SULFATE	15MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2011-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202515-006	MORPHINE SULFATE	50MG/ML	INJECTABLE / INJECTION		RLD, RS	2021-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202515-001	MORPHINE SULFATE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2011-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202515-002	MORPHINE SULFATE	4MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202515-003	MORPHINE SULFATE	8MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202515-004	MORPHINE SULFATE	10MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202515-005	MORPHINE SULFATE	15MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2011-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202515-006	MORPHINE SULFATE	50MG/ML	INJECTABLE / INJECTION		RLD, RS	2021-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202515-001	MORPHINE SULFATE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2011-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202515-002	MORPHINE SULFATE	4MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202515-003	MORPHINE SULFATE	8MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202515-004	MORPHINE SULFATE	10MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202515-005	MORPHINE SULFATE	15MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2011-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202515-006	MORPHINE SULFATE	50MG/ML	INJECTABLE / INJECTION		RLD, RS	2021-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202515-001	MORPHINE SULFATE	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	2011-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202515-002	MORPHINE SULFATE	4MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202515-003	MORPHINE SULFATE	8MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202515-004	MORPHINE SULFATE	10MG/ML	INJECTABLE / INJECTION	AP	RLD	2011-11-14	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 144 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N202515-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202515-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202515-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202515-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202515-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202515-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202515-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202515-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202515-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202515-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202515-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202515-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202515-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202515-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202515-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202515-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202515-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202515-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202515-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202515-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202515-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202515-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202515-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202515-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202515-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202515-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202515-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202515-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202515-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202515-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202515-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202515-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202515-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202515-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202515-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202515-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202515-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202515-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202515-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202515-004	AP	1	`d8e5a09893c0…`

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	Hospira, Inc.	be420e8b-bcb0-49b5-bb4d-1df8b9959809	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202515 application number: NDA202515 ndc (product): 0409-1892 ndc (product): 0409-1893 ndc (product): 0409-1890 ndc (product): 0409-1891
Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	ee8057d1-ed12-4e18-9efa-d83504abf612	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202515 application number: NDA202515

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-1890	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1890	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1890	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1890	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1890	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1890	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1890	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1890	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1890	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1890	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1890	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1891	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1891	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1891	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1891	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1891	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1891	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1891	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1891	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1891	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1892	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1892	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1892	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1892	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1892	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1892	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1893	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1893	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1893	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1893	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1893	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1893	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1893	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1893	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current
0409-1893	Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84678	SUPPL	2026-01-06
84574	SUPPL	2025-12-29
77054	SUPPL	2023-12-19
76965	SUPPL	2023-12-18
70914	SUPPL	2022-05-03
70883	SUPPL	2022-05-02
67311	SUPPL	2021-04-30
67262	SUPPL	2021-04-30
64893	SUPPL	2020-10-19
64891	SUPPL	2020-10-13
60303	SUPPL	2019-10-08
60279	SUPPL	2019-10-07
46428	SUPPL	2016-12-21
46303	SUPPL	2016-12-20
44860	ORIG	2012-06-26
43406	ORIG	2012-06-26
32270	ORIG	2011-11-28
19357	ORIG	2011-11-14