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 43.

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.

Product history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N206544-001MORPHABOND ER15MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-0284e616aacf4f…
2026-09-14 22:38:342026-08N206544-002MORPHABOND ER30MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-0284e616aacf4f…
2026-09-14 22:38:342026-08N206544-003MORPHABOND ER60MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-0284e616aacf4f…
2026-09-14 22:38:342026-08N206544-004MORPHABOND ER100MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-0284e616aacf4f…
2026-08-18 06:07:402026-07N206544-001MORPHABOND ER15MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-02caaa826d4ba7…
2026-08-18 06:07:402026-07N206544-002MORPHABOND ER30MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-02caaa826d4ba7…
2026-08-18 06:07:402026-07N206544-003MORPHABOND ER60MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-02caaa826d4ba7…
2026-08-18 06:07:402026-07N206544-004MORPHABOND ER100MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N206544-001MORPHABOND ER15MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206544-002MORPHABOND ER30MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206544-003MORPHABOND ER60MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206544-004MORPHABOND ER100MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206544-001MORPHABOND ER15MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206544-002MORPHABOND ER30MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206544-003MORPHABOND ER60MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206544-004MORPHABOND ER100MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N206544-001MORPHABOND ER15MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206544-002MORPHABOND ER30MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206544-003MORPHABOND ER60MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206544-004MORPHABOND ER100MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206544-001MORPHABOND ER15MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206544-002MORPHABOND ER30MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206544-003MORPHABOND ER60MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206544-004MORPHABOND ER100MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206544-001MORPHABOND ER15MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206544-002MORPHABOND ER30MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206544-003MORPHABOND ER60MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206544-004MORPHABOND ER100MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206544-001MORPHABOND ER15MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206544-002MORPHABOND ER30MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206544-003MORPHABOND ER60MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206544-004MORPHABOND ER100MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206544-001MORPHABOND ER15MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206544-002MORPHABOND ER30MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206544-003MORPHABOND ER60MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206544-004MORPHABOND ER100MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206544-001MORPHABOND ER15MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206544-002MORPHABOND ER30MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206544-003MORPHABOND ER60MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206544-004MORPHABOND ER100MGTABLET, EXTENDED RELEASE / ORALRLD2015-10-025bbf6a4d5a75…

Observed Orange Book patent history#

Patent history page 1 of 9 · 344 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N206544-001103147882028-08-12Drug product2019-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N206544-00179556192028-08-12Drug product2016-03-2484e616aacf4f…
2026-09-14 22:38:342026-08N206544-002103147882028-08-12Drug product2019-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N206544-00279556192028-08-12Drug product2016-03-2484e616aacf4f…
2026-09-14 22:38:342026-08N206544-003103147882028-08-12Drug product2019-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N206544-00379556192028-08-12Drug product2016-03-2484e616aacf4f…
2026-09-14 22:38:342026-08N206544-004103147882028-08-12Drug product2019-07-1084e616aacf4f…
2026-09-14 22:38:342026-08N206544-00479556192028-08-12Drug product2016-03-2484e616aacf4f…
2026-08-18 06:07:402026-07N206544-001103147882028-08-12Drug product2019-07-10caaa826d4ba7…
2026-08-18 06:07:402026-07N206544-00179556192028-08-12Drug product2016-03-24caaa826d4ba7…
2026-08-18 06:07:402026-07N206544-002103147882028-08-12Drug product2019-07-10caaa826d4ba7…
2026-08-18 06:07:402026-07N206544-00279556192028-08-12Drug product2016-03-24caaa826d4ba7…
2026-08-18 06:07:402026-07N206544-003103147882028-08-12Drug product2019-07-10caaa826d4ba7…
2026-08-18 06:07:402026-07N206544-00379556192028-08-12Drug product2016-03-24caaa826d4ba7…
2026-08-18 06:07:402026-07N206544-004103147882028-08-12Drug product2019-07-10caaa826d4ba7…
2026-08-18 06:07:402026-07N206544-00479556192028-08-12Drug product2016-03-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N206544-001103147882028-08-12Drug product2019-07-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206544-00179556192028-08-12Drug product2016-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206544-002103147882028-08-12Drug product2019-07-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206544-00279556192028-08-12Drug product2016-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206544-003103147882028-08-12Drug product2019-07-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206544-00379556192028-08-12Drug product2016-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206544-004103147882028-08-12Drug product2019-07-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206544-00479556192028-08-12Drug product2016-03-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206544-001103147882028-08-12Drug product2019-07-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206544-00179556192028-08-12Drug product2016-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206544-002103147882028-08-12Drug product2019-07-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206544-00279556192028-08-12Drug product2016-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206544-003103147882028-08-12Drug product2019-07-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206544-00379556192028-08-12Drug product2016-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206544-004103147882028-08-12Drug product2019-07-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206544-00479556192028-08-12Drug product2016-03-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N206544-001103147882028-08-12Drug product2019-07-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206544-00179556192028-08-12Drug product2016-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206544-002103147882028-08-12Drug product2019-07-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206544-00279556192028-08-12Drug product2016-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206544-003103147882028-08-12Drug product2019-07-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206544-00379556192028-08-12Drug product2016-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206544-004103147882028-08-12Drug product2019-07-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206544-00479556192028-08-12Drug product2016-03-246a471c1ec25d…

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 4 of 4 · 73 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepackfd98b881-5466-457b-b5af-f102aec615462024-06-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepack9a1ca529-8268-4be3-b03f-b2f2238cc9dc2024-04-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepackfb9f929b-8c5a-442b-9695-9d3d45272a5e2024-04-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepack73a39ce5-b2ab-47b9-8860-796f1d5bc8d82024-04-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepackad08cd86-3825-4e77-bbe8-f6333a9ca9d72024-04-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATELupin Pharmaceuticals,Inc.d360a33f-6323-4b10-9e81-07e2813c2dbd2024-02-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEBryant Ranch Prepackefccad6e-213b-4335-9a4f-3b81322f77c42024-01-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEBryant Ranch Prepackf4f9a7cd-fa6c-41cd-8c4b-04626cfa410a2024-01-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEBryant Ranch Prepack72e2071a-43d6-4480-bb84-4984a976618b2024-01-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEBryant Ranch Prepack996ac31e-589f-4d5a-84bc-8350e7ea864f2024-01-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEPadagis US LLC649d731b-962a-45df-b043-7e0781e8a5302023-07-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEBryant Ranch Prepackb7b86b6d-9a39-494c-bf65-f62e4cdc58072023-03-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MORPHINE SULFATE
Morphine SulfateMORPHINE SULFATEWinder Laboratories LLCe9a7319a-bf1f-48db-a71e-6d4e6ead95552022-02-28Boxed warning, Warnings, Adverse reactionsName 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
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