Application 206544

Type: NDA
Sponsor: DAIICHI SANKYO INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MORPHABOND ER	MORPHINE SULFATE	TABLET, EXTENDED RELEASE;ORAL	15MG	Yes	No
002	MORPHABOND ER	MORPHINE SULFATE	TABLET, EXTENDED RELEASE;ORAL	30MG	Yes	No
003	MORPHABOND ER	MORPHINE SULFATE	TABLET, EXTENDED RELEASE;ORAL	60MG	Yes	No
004	MORPHABOND ER	MORPHINE SULFATE	TABLET, EXTENDED RELEASE;ORAL	100MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N206544-001	MORPHABOND ER	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02
N206544-002	MORPHABOND ER	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02
N206544-003	MORPHABOND ER	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02
N206544-004	MORPHABOND ER	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N206544-001	10314788	2028-08-12	Drug product	2019-07-10
N206544-001	7955619	2028-08-12	Drug product	2016-03-24
N206544-002	10314788	2028-08-12	Drug product	2019-07-10
N206544-002	7955619	2028-08-12	Drug product	2016-03-24
N206544-003	10314788	2028-08-12	Drug product	2019-07-10
N206544-003	7955619	2028-08-12	Drug product	2016-03-24
N206544-004	10314788	2028-08-12	Drug product	2019-07-10
N206544-004	7955619	2028-08-12	Drug product	2016-03-24

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N206544-001	MORPHABOND ER	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206544-002	MORPHABOND ER	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206544-003	MORPHABOND ER	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206544-004	MORPHABOND ER	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206544-001	MORPHABOND ER	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206544-002	MORPHABOND ER	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206544-003	MORPHABOND ER	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206544-004	MORPHABOND ER	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206544-001	MORPHABOND ER	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206544-002	MORPHABOND ER	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206544-003	MORPHABOND ER	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206544-004	MORPHABOND ER	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206544-001	MORPHABOND ER	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206544-002	MORPHABOND ER	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206544-003	MORPHABOND ER	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206544-004	MORPHABOND ER	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206544-001	MORPHABOND ER	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206544-002	MORPHABOND ER	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206544-003	MORPHABOND ER	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206544-004	MORPHABOND ER	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206544-001	MORPHABOND ER	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206544-002	MORPHABOND ER	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206544-003	MORPHABOND ER	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206544-004	MORPHABOND ER	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206544-001	MORPHABOND ER	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206544-002	MORPHABOND ER	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206544-003	MORPHABOND ER	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206544-004	MORPHABOND ER	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206544-001	MORPHABOND ER	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206544-002	MORPHABOND ER	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206544-003	MORPHABOND ER	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206544-004	MORPHABOND ER	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206544-001	MORPHABOND ER	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206544-002	MORPHABOND ER	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206544-003	MORPHABOND ER	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206544-004	MORPHABOND ER	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206544-001	MORPHABOND ER	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206544-002	MORPHABOND ER	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206544-003	MORPHABOND ER	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206544-004	MORPHABOND ER	100MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-10-02	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 344 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N206544-001	10314788	2028-08-12	Drug product	2019-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206544-001	7955619	2028-08-12	Drug product	2016-03-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206544-002	10314788	2028-08-12	Drug product	2019-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206544-002	7955619	2028-08-12	Drug product	2016-03-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206544-003	10314788	2028-08-12	Drug product	2019-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206544-003	7955619	2028-08-12	Drug product	2016-03-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206544-004	10314788	2028-08-12	Drug product	2019-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206544-004	7955619	2028-08-12	Drug product	2016-03-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206544-001	10314788	2028-08-12	Drug product	2019-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206544-001	7955619	2028-08-12	Drug product	2016-03-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206544-002	10314788	2028-08-12	Drug product	2019-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206544-002	7955619	2028-08-12	Drug product	2016-03-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206544-003	10314788	2028-08-12	Drug product	2019-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206544-003	7955619	2028-08-12	Drug product	2016-03-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206544-004	10314788	2028-08-12	Drug product	2019-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206544-004	7955619	2028-08-12	Drug product	2016-03-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206544-001	10314788	2028-08-12	Drug product	2019-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206544-001	7955619	2028-08-12	Drug product	2016-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206544-002	10314788	2028-08-12	Drug product	2019-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206544-002	7955619	2028-08-12	Drug product	2016-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206544-003	10314788	2028-08-12	Drug product	2019-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206544-003	7955619	2028-08-12	Drug product	2016-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206544-004	10314788	2028-08-12	Drug product	2019-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206544-004	7955619	2028-08-12	Drug product	2016-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206544-001	10314788	2028-08-12	Drug product	2019-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206544-001	7955619	2028-08-12	Drug product	2016-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206544-002	10314788	2028-08-12	Drug product	2019-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206544-002	7955619	2028-08-12	Drug product	2016-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206544-003	10314788	2028-08-12	Drug product	2019-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206544-003	7955619	2028-08-12	Drug product	2016-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206544-004	10314788	2028-08-12	Drug product	2019-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206544-004	7955619	2028-08-12	Drug product	2016-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206544-001	10314788	2028-08-12	Drug product	2019-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206544-001	7955619	2028-08-12	Drug product	2016-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206544-002	10314788	2028-08-12	Drug product	2019-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206544-002	7955619	2028-08-12	Drug product	2016-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206544-003	10314788	2028-08-12	Drug product	2019-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206544-003	7955619	2028-08-12	Drug product	2016-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206544-004	10314788	2028-08-12	Drug product	2019-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206544-004	7955619	2028-08-12	Drug product	2016-03-24	`6a471c1ec25d…`

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 2 of 4 · 73 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Morphine Sulfate	MORPHINE SULFATE	American Health Packaging	5422cdac-8073-41fc-8665-ffe9797f5c02	2026-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback 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 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 generic name: MORPHINE SULFATE
Morphine Sulfate Extended Release	MORPHINE SULFATE	Bryant Ranch Prepack	c94d9da6-7a12-44ee-a38f-3323ee27842c	2026-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate ER	MORPHINE SULFATE	Bryant Ranch Prepack	872ceecb-1f14-7a43-7451-e4650a01fbd9	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	cc3b491c-a206-3027-54f0-f87c0dd40a7f	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine sulfate	MORPHINE SULFATE	Sun Pharmaceutical Industries, Inc.	736c9b80-682c-4cda-bf18-61b18de0bd39	2026-03-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine sulfate	MORPHINE SULFATE	Actavis Pharma, Inc.	2da87bfa-11fd-43e3-8fef-d16ebeb15680	2026-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
MITIGO	MORPHINE SULFATE	Piramal Critical Care, Inc.	728f3d83-9a63-0c1f-e053-2a91aa0ac7db	2026-02-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Cranbury Pharmaceuticals, LLC	d8598654-94ad-4cfb-81d2-9b68e013a428	2026-02-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	07993f6c-146b-4728-a2da-6e93089f78ff	2026-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	American Health Packaging	66a3f607-7f48-490f-84dd-b74dd1ee39e5	2026-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Hikma Pharmaceuticals USA Inc.	ca359246-4674-4b32-b8b2-673d32b7112f	2026-02-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Hikma Pharmaceuticals USA Inc.	3c847554-3b4b-4d24-a145-2ef7e9b83699	2026-02-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	3a89d0ca-4ff8-4bdc-8ea8-9ad591ce7226	2026-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	PAI Holdings, LLC dba PAI Pharma	9405556c-20e0-4e47-b1b0-7872bcc6517e	2026-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	be420e8b-bcb0-49b5-bb4d-1df8b9959809	2025-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	ee8057d1-ed12-4e18-9efa-d83504abf612	2025-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Duramorph	MORPHINE SULFATE	Hikma Pharmaceuticals USA Inc.	ebb18761-e5c4-4238-bb84-f9549f500210	2025-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE

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 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65597-301	MorphaBond	morphine sulfate	Daiichi Sankyo Inc.	NDA	Current
65597-301	MorphaBond	morphine sulfate	Daiichi Sankyo Inc.	NDA	Current
65597-301	MorphaBond	morphine sulfate	Daiichi Sankyo Inc.	NDA	Current
65597-301	MorphaBond	morphine sulfate	Daiichi Sankyo Inc.	NDA	Current
65597-302	MorphaBond	morphine sulfate	Daiichi Sankyo Inc.	NDA	Current
65597-302	MorphaBond	morphine sulfate	Daiichi Sankyo Inc.	NDA	Current
65597-302	MorphaBond	morphine sulfate	Daiichi Sankyo Inc.	NDA	Current
65597-302	MorphaBond	morphine sulfate	Daiichi Sankyo Inc.	NDA	Current
65597-303	MorphaBond	morphine sulfate	Daiichi Sankyo Inc.	NDA	Current
65597-303	MorphaBond	morphine sulfate	Daiichi Sankyo Inc.	NDA	Current
65597-303	MorphaBond	morphine sulfate	Daiichi Sankyo Inc.	NDA	Current
65597-303	MorphaBond	morphine sulfate	Daiichi Sankyo Inc.	NDA	Current
65597-304	MorphaBond	morphine sulfate	Daiichi Sankyo Inc.	NDA	Current
65597-304	MorphaBond	morphine sulfate	Daiichi Sankyo Inc.	NDA	Current
65597-304	MorphaBond	morphine sulfate	Daiichi Sankyo Inc.	NDA	Current
65597-304	MorphaBond	morphine sulfate	Daiichi Sankyo Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
60429	SUPPL	2019-10-09
60428	SUPPL	2019-10-09
60371	SUPPL	2019-10-08
57123	SUPPL	2019-02-04
57092	SUPPL	2019-01-02
55677	SUPPL	2018-10-01
55676	SUPPL	2018-10-01
55543	SUPPL	2018-09-21
55542	SUPPL	2018-09-21
54426	SUPPL	2018-06-04
54424	SUPPL	2018-06-04
48592	SUPPL	2017-05-31
46440	SUPPL	2016-12-21
46439	SUPPL	2016-12-21
46323	SUPPL	2016-12-20
46322	SUPPL	2016-12-20
46066	ORIG	2016-10-20
46065	ORIG	2016-10-20
45453	SUPPL	2016-10-03
10579	SUPPL	2016-04-22
44601	ORIG	2015-11-04
24128	ORIG	2015-10-16
40556	ORIG	2015-10-09
10578	ORIG	2015-10-09