FDA.reportPublic FDA data

Application 206544

Type
NDA
Sponsor
DAIICHI SANKYO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MORPHABOND ERMORPHINE SULFATETABLET, EXTENDED RELEASE;ORAL15MGYesNo
002MORPHABOND ERMORPHINE SULFATETABLET, EXTENDED RELEASE;ORAL30MGYesNo
003MORPHABOND ERMORPHINE SULFATETABLET, EXTENDED RELEASE;ORAL60MGYesNo
004MORPHABOND ERMORPHINE SULFATETABLET, EXTENDED RELEASE;ORAL100MGYesYes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N206544-001MORPHABOND ERMORPHINE SULFATE15MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-02
N206544-002MORPHABOND ERMORPHINE SULFATE30MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-02
N206544-003MORPHABOND ERMORPHINE SULFATE60MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-02
N206544-004MORPHABOND ERMORPHINE SULFATE100MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-02

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N206544-001103147882028-08-12Drug product2019-07-10
N206544-00179556192028-08-12Drug product2016-03-24
N206544-002103147882028-08-12Drug product2019-07-10
N206544-00279556192028-08-12Drug product2016-03-24
N206544-003103147882028-08-12Drug product2019-07-10
N206544-00379556192028-08-12Drug product2016-03-24
N206544-004103147882028-08-12Drug product2019-07-10
N206544-00479556192028-08-12Drug product2016-03-24

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N206544-001MORPHABOND ER15MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-02a50c72e98297…
2026-08-01 22:54:322026-06N206544-002MORPHABOND ER30MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-02a50c72e98297…
2026-08-01 22:54:322026-06N206544-003MORPHABOND ER60MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-02a50c72e98297…
2026-08-01 22:54:322026-06N206544-004MORPHABOND ER100MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-02a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N206544-001103147882028-08-12Drug product2019-07-10a50c72e98297…
2026-08-01 22:54:322026-06N206544-00179556192028-08-12Drug product2016-03-24a50c72e98297…
2026-08-01 22:54:322026-06N206544-002103147882028-08-12Drug product2019-07-10a50c72e98297…
2026-08-01 22:54:322026-06N206544-00279556192028-08-12Drug product2016-03-24a50c72e98297…
2026-08-01 22:54:322026-06N206544-003103147882028-08-12Drug product2019-07-10a50c72e98297…
2026-08-01 22:54:322026-06N206544-00379556192028-08-12Drug product2016-03-24a50c72e98297…
2026-08-01 22:54:322026-06N206544-004103147882028-08-12Drug product2019-07-10a50c72e98297…
2026-08-01 22:54:322026-06N206544-00479556192028-08-12Drug product2016-03-24a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 4 · 71 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Morphine SulfateMORPHINE SULFATESpecGx LLC242c2512-1d49-486b-a9c3-6905f667799e2026-07-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepack595243fe-a4b1-479a-99d6-a084a41818912026-07-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEHikma Pharmaceuticals USA Inc.6023606c-150c-40c5-9175-598efe2a56c32026-07-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEPrecision Dose, Inc.6654b91e-3b3f-4062-ac65-a2a70f942da42026-06-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEPrecision Dose, Inc.bb6b3439-9f0c-45f5-bf6f-c7a971af0a8f2026-06-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEPrecision Dose, Inc.76966c05-df75-4072-ae99-97e42f91ab752026-06-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEPrecision Dose, Inc.67f0ee8d-696e-4c08-9007-3df0e3988bad2026-06-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine Sulfate Extended ReleaseMORPHINE SULFATEMajor Pharmaceuticalsdbb37dfd-0196-45f7-b9ca-393f56cf1d282026-05-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEBryant Ranch Prepack367d508b-3226-42a9-8dc6-f67cdc9979f32026-05-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEPrecision Dose Inc.8d800d8e-8fe2-453b-a8ac-dcf7c47e55fc2026-05-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
MS ContinMORPHINE SULFATERhodes Pharmaceuticals LLCc354b3bf-86c0-4bb8-8b1f-be21649426982026-05-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine Sulfate Extended ReleaseMORPHINE SULFATERhodes Pharmaceuticals LLC19c7d9cc-6ce2-4c5c-8c3f-c24fd33428042026-05-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEHospira, Inc.1d181906-f3ec-4222-1883-e61577a3122e2026-04-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine Sulfate Extended ReleaseMORPHINE SULFATEBryant Ranch Prepack2dd52157-3121-41ed-abc2-99b269531e562026-04-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
MORPHINE SULFATEMORPHINE SULFATEBryant Ranch Prepackd1b0b4ac-69d9-44bf-b7a3-229bd89b9fd62026-04-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine Sulfate Extended ReleaseMORPHINE SULFATEBryant Ranch Prepackc94d9da6-7a12-44ee-a38f-3323ee27842c2026-04-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine Sulfate ERMORPHINE SULFATEBryant Ranch Prepack872ceecb-1f14-7a43-7451-e4650a01fbd92026-04-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEBryant Ranch Prepackcc3b491c-a206-3027-54f0-f87c0dd40a7f2026-04-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine sulfateMORPHINE SULFATESun Pharmaceutical Industries, Inc.736c9b80-682c-4cda-bf18-61b18de0bd392026-03-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine sulfateMORPHINE SULFATEActavis Pharma, Inc.2da87bfa-11fd-43e3-8fef-d16ebeb156802026-03-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65597-301MorphaBondmorphine sulfateDaiichi Sankyo Inc.NDACurrent
65597-301MorphaBondmorphine sulfateDaiichi Sankyo Inc.NDACurrent
65597-301MorphaBondmorphine sulfateDaiichi Sankyo Inc.NDACurrent
65597-301MorphaBondmorphine sulfateDaiichi Sankyo Inc.NDACurrent
65597-302MorphaBondmorphine sulfateDaiichi Sankyo Inc.NDACurrent
65597-302MorphaBondmorphine sulfateDaiichi Sankyo Inc.NDACurrent
65597-302MorphaBondmorphine sulfateDaiichi Sankyo Inc.NDACurrent
65597-302MorphaBondmorphine sulfateDaiichi Sankyo Inc.NDACurrent
65597-303MorphaBondmorphine sulfateDaiichi Sankyo Inc.NDACurrent
65597-303MorphaBondmorphine sulfateDaiichi Sankyo Inc.NDACurrent
65597-303MorphaBondmorphine sulfateDaiichi Sankyo Inc.NDACurrent
65597-303MorphaBondmorphine sulfateDaiichi Sankyo Inc.NDACurrent
65597-304MorphaBondmorphine sulfateDaiichi Sankyo Inc.NDACurrent
65597-304MorphaBondmorphine sulfateDaiichi Sankyo Inc.NDACurrent
65597-304MorphaBondmorphine sulfateDaiichi Sankyo Inc.NDACurrent
65597-304MorphaBondmorphine sulfateDaiichi Sankyo Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60429SUPPL2019-10-09
60428SUPPL2019-10-09
60371SUPPL2019-10-08
57123SUPPL2019-02-04
57092SUPPL2019-01-02
55677SUPPL2018-10-01
55676SUPPL2018-10-01
55543SUPPL2018-09-21
55542SUPPL2018-09-21
54426SUPPL2018-06-04
54424SUPPL2018-06-04
48592SUPPL2017-05-31
46440SUPPL2016-12-21
46439SUPPL2016-12-21
46323SUPPL2016-12-20
46322SUPPL2016-12-20
46066ORIG2016-10-20
46065ORIG2016-10-20
45453SUPPL2016-10-03
10579SUPPL2016-04-22
44601ORIG2015-11-04
24128ORIG2015-10-16
40556ORIG2015-10-09
10578ORIG2015-10-09