Application 022195

Type: NDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MORPHINE SULFATE	MORPHINE SULFATE	SOLUTION;ORAL	10MG/5ML	Yes	No
002	MORPHINE SULFATE	MORPHINE SULFATE	SOLUTION;ORAL	20MG/5ML	Yes	No
003	MORPHINE SULFATE	MORPHINE SULFATE	SOLUTION;ORAL	100MG/5ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022195-001	MORPHINE SULFATE	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17
N022195-002	MORPHINE SULFATE	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17
N022195-003	MORPHINE SULFATE	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N022195-001	AA
N022195-002	AA
N022195-003	AA

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 4 · 123 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
2026-02-19 14:30 UTC	2026-02	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL		RLD	2008-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 122 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022195-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022195-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022195-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022195-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022195-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022195-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022195-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022195-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022195-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022195-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022195-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022195-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022195-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022195-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022195-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022195-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022195-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022195-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022195-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022195-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022195-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022195-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022195-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022195-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022195-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022195-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022195-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022195-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022195-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022195-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022195-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022195-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022195-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022195-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022195-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022195-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022195-002	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022195-003	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022195-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022195-002	AA	1	`8072bd15b7f6…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022195-001	NPP	2024-06-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022195-002	NPP	2024-06-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022195-001	NPP	2024-06-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022195-002	NPP	2024-06-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022195-001	NPP	2024-06-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022195-002	NPP	2024-06-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022195-001	NPP	2024-06-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022195-002	NPP	2024-06-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022195-001	NPP	2024-06-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022195-002	NPP	2024-06-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022195-001	NPP	2024-06-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022195-002	NPP	2024-06-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022195-001	NPP	2024-06-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022195-002	NPP	2024-06-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022195-001	NPP	2024-06-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022195-002	NPP	2024-06-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022195-001	NPP	2024-06-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022195-002	NPP	2024-06-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022195-001	NPP	2024-06-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022195-002	NPP	2024-06-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022195-001	NPP	2024-06-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022195-002	NPP	2024-06-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022195-001	NPP	2024-06-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022195-002	NPP	2024-06-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022195-001	NPP	2024-06-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022195-002	NPP	2024-06-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022195-001	NPP	2024-06-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022195-002	NPP	2024-06-02	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022195-001	NPP	2024-06-02	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022195-002	NPP	2024-06-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022195-001	NPP	2024-06-02	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N022195-002	NPP	2024-06-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022195-001	NPP	2024-06-02	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N022195-002	NPP	2024-06-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022195-001	NPP	2024-06-02	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022195-002	NPP	2024-06-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022195-001	NPP	2024-06-02	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022195-002	NPP	2024-06-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022195-001	NPP	2024-06-02	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022195-002	NPP	2024-06-02	`a67488948f0b…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Morphine Sulfate	MORPHINE SULFATE	Precision Dose, Inc.	6654b91e-3b3f-4062-ac65-a2a70f942da4	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022195 application number: NDA022195
Morphine Sulfate	MORPHINE SULFATE	Precision Dose, Inc.	bb6b3439-9f0c-45f5-bf6f-c7a971af0a8f	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022195 application number: NDA022195 ndc (product): 68094-056
Morphine Sulfate	MORPHINE SULFATE	Precision Dose, Inc.	76966c05-df75-4072-ae99-97e42f91ab75	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022195 application number: NDA022195
Morphine Sulfate	MORPHINE SULFATE	Precision Dose, Inc.	67f0ee8d-696e-4c08-9007-3df0e3988bad	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022195 application number: NDA022195 ndc (product): 68094-045
Morphine Sulfate	MORPHINE SULFATE	Precision Dose Inc.	8d800d8e-8fe2-453b-a8ac-dcf7c47e55fc	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022195 application number: NDA022195 ndc (product): 68094-001
Morphine Sulfate	MORPHINE SULFATE	Hikma Pharmaceuticals USA Inc.	ca359246-4674-4b32-b8b2-673d32b7112f	2026-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022195 application number: NDA022195 ndc (product): 0054-0404 ndc (product): 0054-0238 ndc (product): 0054-0237 ndc (product): 0054-0517
Morphine Sulfate	MORPHINE SULFATE	Precision Dose, Inc.	ae57637e-a86a-4ea5-9c68-47d98153d41a	2026-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022195 application number: NDA022195
Morphine Sulfate	MORPHINE SULFATE	American Health Packaging	9f1ba2a2-d8ac-4f59-a587-fe413e56dcdb	2025-11-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022195 application number: NDA022195
Morphine Sulfate	MORPHINE SULFATE	PAI Holdings, LLC dba PAI Pharma	6e32b869-31c7-48c1-98ae-b21bd28151d7	2024-11-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022195 application number: NDA022195 ndc (product): 0121-0904
Morphine Sulfate	MORPHINE SULFATE	Precision Dose, Inc.	cc50d3c1-b4c8-4edc-9aa0-844d2fed45fb	2024-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022195 application number: NDA022195

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 53 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0237	Morphine Sulfate	Morphine Sulfate	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-0237	Morphine Sulfate	Morphine Sulfate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-0237	Morphine Sulfate	Morphine Sulfate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-0237	Morphine Sulfate	Morphine Sulfate	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-0237	Morphine Sulfate	Morphine Sulfate	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-0237	Morphine Sulfate	Morphine Sulfate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-0238	Morphine Sulfate	Morphine Sulfate	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-0238	Morphine Sulfate	Morphine Sulfate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-0238	Morphine Sulfate	Morphine Sulfate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-0238	Morphine Sulfate	Morphine Sulfate	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-0238	Morphine Sulfate	Morphine Sulfate	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-0238	Morphine Sulfate	Morphine Sulfate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-0404	Morphine Sulfate	Morphine Sulfate	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-0404	Morphine Sulfate	Morphine Sulfate	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-0404	Morphine Sulfate	Morphine Sulfate	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-0404	Morphine Sulfate	Morphine Sulfate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-0404	Morphine Sulfate	Morphine Sulfate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-0517	Morphine Sulfate	Morphine Sulfate	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-0517	Morphine Sulfate	Morphine Sulfate	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-0517	Morphine Sulfate	Morphine Sulfate	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-0517	Morphine Sulfate	Morphine Sulfate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-0517	Morphine Sulfate	Morphine Sulfate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0121-0904	Morphine Sulfate	Morphine Sulfate	Pharmaceutical Associates, Inc.	NDA	Current
0121-0904	Morphine Sulfate	Morphine Sulfate	Pharmaceutical Associates, Inc.	NDA	Current
0121-0904	Morphine Sulfate	Morphine Sulfate	Pharmaceutical Associates, Inc.	NDA	Current
17856-0237	Morphine Sulfate	Morphine Sulfate	ATLANTIC BIOLOGICALS CORP.	NDA	Current
17856-0237	Morphine Sulfate	Morphine Sulfate	Atlantic Biologicals Corps	NDA	Current
17856-0238	Morphine Sulfate	Morphine Sulfate	ATLANTIC BIOLOGICALS CORP.	NDA	Current
17856-0238	Morphine Sulfate	Morphine Sulfate	Atlantic Biologicals Corps	NDA	Current
17856-0403	Morphine Sulfate	Morphine Sulfate	ATLANTIC BIOLOGICALS CORP.	NDA	Current
17856-0406	Morphine Sulfate	Morphine Sulfate	ATLANTIC BIOLOGICALS CORP.	NDA	Current
17856-0517	Morphine Sulfate	Morphine Sulfate	ATLANTIC BIOLOGICALS CORP.	NDA	Current
17856-0517	Morphine Sulfate	Morphine Sulfate	ATLANTIC BIOLOGICALS CORP.	NDA	Current
17856-0517	Morphine Sulfate	Morphine Sulfate	ATLANTIC BIOLOGICALS CORP.	NDA	Current
49999-849	Morphine Sulfate	Morphine Sulfate	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	NDA	Current
49999-849	Morphine Sulfate	Morphine Sulfate	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	NDA	Current
49999-849	Morphine Sulfate	Morphine Sulfate	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	NDA	Current
52959-138	Morphine Sulfate	Morphine Sulfate	H.J. Harkins Company, Inc.	NDA	Current
52959-182	Morphine Sulfate	Morphine Sulfate	H.J. Harkins Company, Inc.	NDA	Current
68094-001	Morphine Sulfate	Morphine Sulfate	Precision Dose Inc.	NDA	Current
68094-001	Morphine Sulfate	Morphine Sulfate	Precision Dose Inc.	NDA	Current
68094-001	Morphine Sulfate	Morphine Sulfate	Precision Dose Inc.	NDA	Current
68094-001	Morphine Sulfate	Morphine Sulfate	Precision Dose Inc.	NDA	Current
68094-001	Morphine Sulfate	Morphine Sulfate	Precision Dose Inc.	NDA	Current
68094-045	Morphine Sulfate	Morphine Sulfate	Precision Dose, Inc.	NDA	Current
68094-045	Morphine Sulfate	Morphine Sulfate	Precision Dose, Inc.	NDA	Current
68094-056	Morphine Sulfate	Morphine Sulfate	Precision Dose, Inc.	NDA	Current
68094-754	Morphine Sulfate	Morphine Sulfate	Precision Dose Inc.	NDA	Current
68094-754	Morphine Sulfate	Morphine Sulfate	Precision Dose Inc.	NDA	Current
68094-754	Morphine Sulfate	Morphine Sulfate	Precision Dose Inc.	NDA	Current
68094-754	Morphine Sulfate	Morphine Sulfate	Precision Dose Inc.	NDA	Current
68094-755	Morphine Sulfate	Morphine Sulfate	Precision Dose Inc.	NDA	Current
68094-755	Morphine Sulfate	Morphine Sulfate	Precision Dose Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84690	SUPPL	2026-01-06
84607	SUPPL	2025-12-31
80072	SUPPL	2024-11-04
77007	SUPPL	2023-12-19
76924	SUPPL	2023-12-18
76921	SUPPL	2023-12-18
76235	ORIG	2023-11-03
68177	SUPPL	2021-07-26
68167	SUPPL	2021-07-23
67692	SUPPL	2021-06-03
67690	SUPPL	2021-06-03
67689	SUPPL	2021-06-03
66601	SUPPL	2021-03-08
66600	SUPPL	2021-03-08
66555	SUPPL	2021-03-05
60375	SUPPL	2019-10-08
60374	SUPPL	2019-10-08
60362	SUPPL	2019-10-08
55995	SUPPL	2018-10-17
55994	SUPPL	2018-10-17
55695	SUPPL	2018-10-01
55694	SUPPL	2018-10-01
46347	SUPPL	2016-12-21
46295	SUPPL	2016-12-20
38366	SUPPL	2015-04-23
29386	SUPPL	2015-04-22
7027	SUPPL	2014-01-14
7026	SUPPL	2012-01-25
17067	SUPPL	2012-01-23
7025	SUPPL	2011-10-20
38365	SUPPL	2010-01-29
7024	SUPPL	2010-01-29
24256	ORIG	2009-04-01
21956	ORIG	2009-04-01
17066	ORIG	2008-03-24
29385	ORIG	2008-03-19