Application 205758

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MORPHINE SULFATE	MORPHINE SULFATE	INJECTABLE;INJECTION	4MG/ML	No	No
002	MORPHINE SULFATE	MORPHINE SULFATE	INJECTABLE;INJECTION	8MG/ML	No	No
003	MORPHINE SULFATE	MORPHINE SULFATE	INJECTABLE;INJECTION	10MG/ML	No	No

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

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
A205758-001	MORPHINE SULFATE	MORPHINE SULFATE	4MG/ML	INJECTABLE / INJECTION	AP	RS	2015-05-21
A205758-002	MORPHINE SULFATE	MORPHINE SULFATE	8MG/ML	INJECTABLE / INJECTION	AP	RS	2015-05-21
A205758-003	MORPHINE SULFATE	MORPHINE SULFATE	10MG/ML	INJECTABLE / INJECTION	AP		2015-05-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205758-001	AP
A205758-002	AP
A205758-003	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 4 · 126 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	A205758-001	MORPHINE SULFATE	4MG/ML	INJECTABLE / INJECTION	AP	RS	2015-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205758-002	MORPHINE SULFATE	8MG/ML	INJECTABLE / INJECTION	AP	RS	2015-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205758-003	MORPHINE SULFATE	10MG/ML	INJECTABLE / INJECTION	AP		2015-05-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205758-001	MORPHINE SULFATE	4MG/ML	INJECTABLE / INJECTION	AP	RS	2015-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205758-002	MORPHINE SULFATE	8MG/ML	INJECTABLE / INJECTION	AP	RS	2015-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205758-003	MORPHINE SULFATE	10MG/ML	INJECTABLE / INJECTION	AP		2015-05-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205758-001	MORPHINE SULFATE	4MG/ML	INJECTABLE / INJECTION	AP	RS	2015-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205758-002	MORPHINE SULFATE	8MG/ML	INJECTABLE / INJECTION	AP	RS	2015-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205758-003	MORPHINE SULFATE	10MG/ML	INJECTABLE / INJECTION	AP		2015-05-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205758-001	MORPHINE SULFATE	4MG/ML	INJECTABLE / INJECTION	AP	RS	2015-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205758-002	MORPHINE SULFATE	8MG/ML	INJECTABLE / INJECTION	AP	RS	2015-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205758-003	MORPHINE SULFATE	10MG/ML	INJECTABLE / INJECTION	AP		2015-05-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205758-001	MORPHINE SULFATE	4MG/ML	INJECTABLE / INJECTION	AP	RS	2015-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205758-002	MORPHINE SULFATE	8MG/ML	INJECTABLE / INJECTION	AP	RS	2015-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205758-003	MORPHINE SULFATE	10MG/ML	INJECTABLE / INJECTION	AP		2015-05-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205758-001	MORPHINE SULFATE	4MG/ML	INJECTABLE / INJECTION	AP	RS	2015-05-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205758-002	MORPHINE SULFATE	8MG/ML	INJECTABLE / INJECTION	AP	RS	2015-05-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205758-003	MORPHINE SULFATE	10MG/ML	INJECTABLE / INJECTION	AP		2015-05-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205758-001	MORPHINE SULFATE	4MG/ML	INJECTABLE / INJECTION	AP	RS	2015-05-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205758-002	MORPHINE SULFATE	8MG/ML	INJECTABLE / INJECTION	AP	RS	2015-05-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205758-003	MORPHINE SULFATE	10MG/ML	INJECTABLE / INJECTION	AP		2015-05-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205758-001	MORPHINE SULFATE	4MG/ML	INJECTABLE / INJECTION	AP	RS	2015-05-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205758-002	MORPHINE SULFATE	8MG/ML	INJECTABLE / INJECTION	AP	RS	2015-05-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205758-003	MORPHINE SULFATE	10MG/ML	INJECTABLE / INJECTION	AP		2015-05-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205758-001	MORPHINE SULFATE	4MG/ML	INJECTABLE / INJECTION	AP	RS	2015-05-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205758-002	MORPHINE SULFATE	8MG/ML	INJECTABLE / INJECTION	AP	RS	2015-05-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205758-003	MORPHINE SULFATE	10MG/ML	INJECTABLE / INJECTION	AP		2015-05-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205758-001	MORPHINE SULFATE	4MG/ML	INJECTABLE / INJECTION	AP	RS	2015-05-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205758-002	MORPHINE SULFATE	8MG/ML	INJECTABLE / INJECTION	AP	RS	2015-05-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205758-003	MORPHINE SULFATE	10MG/ML	INJECTABLE / INJECTION	AP		2015-05-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205758-001	MORPHINE SULFATE	4MG/ML	INJECTABLE / INJECTION	AP	RS	2015-05-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205758-002	MORPHINE SULFATE	8MG/ML	INJECTABLE / INJECTION	AP	RS	2015-05-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205758-003	MORPHINE SULFATE	10MG/ML	INJECTABLE / INJECTION	AP		2015-05-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205758-001	MORPHINE SULFATE	4MG/ML	INJECTABLE / INJECTION	AP	RS	2015-05-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205758-002	MORPHINE SULFATE	8MG/ML	INJECTABLE / INJECTION	AP	RS	2015-05-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205758-003	MORPHINE SULFATE	10MG/ML	INJECTABLE / INJECTION	AP		2015-05-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205758-001	MORPHINE SULFATE	4MG/ML	INJECTABLE / INJECTION	AP	RS	2015-05-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205758-002	MORPHINE SULFATE	8MG/ML	INJECTABLE / INJECTION	AP	RS	2015-05-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205758-003	MORPHINE SULFATE	10MG/ML	INJECTABLE / INJECTION	AP		2015-05-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205758-001	MORPHINE SULFATE	4MG/ML	INJECTABLE / INJECTION	AP	RS	2015-05-21	`1e350fbaab3a…`

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
2026-08-18 06:07:40	2026-07	A205758-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205758-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205758-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205758-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205758-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205758-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205758-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205758-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205758-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205758-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205758-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205758-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205758-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205758-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205758-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205758-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205758-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205758-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205758-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205758-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205758-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205758-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205758-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205758-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205758-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205758-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205758-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205758-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205758-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205758-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205758-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205758-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205758-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205758-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205758-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205758-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205758-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205758-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205758-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205758-001	AP	1	`1e350fbaab3a…`

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	Hikma Pharmaceuticals USA Inc.	6023606c-150c-40c5-9175-598efe2a56c3	2026-07-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205758 application number: ANDA205758 ndc (product): 0641-6127 ndc (product): 0641-6125 ndc (product): 0641-6126
Morphine Sulfate	MORPHINE SULFATE	Civica, Inc.	9362eca1-2bc9-4f72-8895-0b9179bfeb2b	2025-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205758 application number: ANDA205758 ndc (product): 72572-440

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0641-6125	Morphine Sulfate	Morphine Sulfate	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6125	Morphine Sulfate	Morphine Sulfate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6126	Morphine Sulfate	Morphine Sulfate	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6126	Morphine Sulfate	Morphine Sulfate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6127	Morphine Sulfate	Morphine Sulfate	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6127	Morphine Sulfate	Morphine Sulfate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
72572-440	Morphine Sulfate	Morphine Sulfate	Civica, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32717	ORIG	2015-05-27