Application 077855

Type: ANDA
Sponsor: NESHER PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MORPHINE SULFATE	MORPHINE SULFATE	TABLET, EXTENDED RELEASE;ORAL	100MG	No	No
002	MORPHINE SULFATE	MORPHINE SULFATE	TABLET, EXTENDED RELEASE;ORAL	200MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077855-001	MORPHINE SULFATE	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL			2007-09-27
A077855-002	MORPHINE SULFATE	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL			2007-09-27

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.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-09-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-09-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077855-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077855-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A077855-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077855-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077855-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077855-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077855-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077855-002	AB	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.

Matched openFDA labels page 1 of 4 · 74 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Morphine Sulfate	MORPHINE SULFATE	Redpharm Drug	58476a6b-b54b-5491-e063-6394a90a38c6	2026-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	SpecGx LLC	8b69f67f-30b3-4982-953e-5a4b87ec6ac6	2026-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
MORPHINE SULFATE	MORPHINE SULFATE	St. Mary's Medical Park Pharmacy	57ee014e-744e-65e1-e063-6394a90a8c93	2026-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MORPHINE SULFATE generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	SpecGx LLC	242c2512-1d49-486b-a9c3-6905f667799e	2026-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	595243fe-a4b1-479a-99d6-a084a4181891	2026-07-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Hikma Pharmaceuticals USA Inc.	6023606c-150c-40c5-9175-598efe2a56c3	2026-07-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Hikma Pharmaceuticals USA Inc.	69a0d5be-3211-4b7f-962b-e9d9a507321f	2026-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Precision Dose, Inc.	6654b91e-3b3f-4062-ac65-a2a70f942da4	2026-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Precision Dose, Inc.	bb6b3439-9f0c-45f5-bf6f-c7a971af0a8f	2026-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Precision Dose, Inc.	76966c05-df75-4072-ae99-97e42f91ab75	2026-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Precision Dose, Inc.	67f0ee8d-696e-4c08-9007-3df0e3988bad	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate Extended Release	MORPHINE SULFATE	Major Pharmaceuticals	dbb37dfd-0196-45f7-b9ca-393f56cf1d28	2026-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	367d508b-3226-42a9-8dc6-f67cdc9979f3	2026-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Precision Dose Inc.	8d800d8e-8fe2-453b-a8ac-dcf7c47e55fc	2026-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
MS Contin	MORPHINE SULFATE	Rhodes Pharmaceuticals LLC	c354b3bf-86c0-4bb8-8b1f-be2164942698	2026-05-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate Extended Release	MORPHINE SULFATE	Rhodes Pharmaceuticals LLC	19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804	2026-05-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	American Health Packaging	5422cdac-8073-41fc-8665-ffe9797f5c02	2026-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	1d181906-f3ec-4222-1883-e61577a3122e	2026-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate Extended Release	MORPHINE SULFATE	Bryant Ranch Prepack	2dd52157-3121-41ed-abc2-99b269531e56	2026-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
MORPHINE SULFATE	MORPHINE SULFATE	Bryant Ranch Prepack	d1b0b4ac-69d9-44bf-b7a3-229bd89b9fd6	2026-04-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MORPHINE SULFATE generic name: MORPHINE SULFATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
58177-340	Morphine Sulfate	Morphine Sulfate	ETHEX Corporation	ANDA	Current
58177-380	Morphine Sulfate	Morphine Sulfate	ETHEX Corporation	ANDA	Current
68382-906	MORPHINE SULFATE	MORPHINE SULFATE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-906	MORPHINE SULFATE	MORPHINE SULFATE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-906	MORPHINE SULFATE	MORPHINE SULFATE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-906	MORPHINE SULFATE	MORPHINE SULFATE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-907	MORPHINE SULFATE	MORPHINE SULFATE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-907	MORPHINE SULFATE	MORPHINE SULFATE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-907	MORPHINE SULFATE	MORPHINE SULFATE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-907	MORPHINE SULFATE	MORPHINE SULFATE	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current