Application 022266

Type
NDA
Sponsor
BDSI

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ONSOLISFENTANYL CITRATEFILM;BUCCALEQ 0.2MG BASENoNo
002ONSOLISFENTANYL CITRATEFILM;BUCCALEQ 0.4MG BASENoNo
003ONSOLISFENTANYL CITRATEFILM;BUCCALEQ 0.6MG BASENoNo
004ONSOLISFENTANYL CITRATEFILM;BUCCALEQ 0.8MG BASENoNo
005ONSOLISFENTANYL CITRATEFILM;BUCCALEQ 1.2MG BASENoNo

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022266-001ONSOLISFENTANYL CITRATEEQ 0.2MG BASEFILM / BUCCAL2009-07-16
N022266-002ONSOLISFENTANYL CITRATEEQ 0.4MG BASEFILM / BUCCAL2009-07-16
N022266-003ONSOLISFENTANYL CITRATEEQ 0.6MG BASEFILM / BUCCAL2009-07-16
N022266-004ONSOLISFENTANYL CITRATEEQ 0.8MG BASEFILM / BUCCAL2009-07-16
N022266-005ONSOLISFENTANYL CITRATEEQ 1.2MG BASEFILM / BUCCAL2009-07-16

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022266-00195972882027-07-23U-767Drug product2017-04-03
N022266-00295972882027-07-23U-767Drug product2017-04-03
N022266-00395972882027-07-23U-767Drug product2017-04-03
N022266-00495972882027-07-23U-767Drug product2017-04-03
N022266-00595972882027-07-23U-767Drug product2017-04-03

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 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022266-001ONSOLISEQ 0.2MG BASEFILM / BUCCAL2009-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022266-002ONSOLISEQ 0.4MG BASEFILM / BUCCAL2009-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022266-003ONSOLISEQ 0.6MG BASEFILM / BUCCAL2009-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022266-004ONSOLISEQ 0.8MG BASEFILM / BUCCAL2009-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022266-005ONSOLISEQ 1.2MG BASEFILM / BUCCAL2009-07-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022266-001ONSOLISEQ 0.2MG BASEFILM / BUCCAL2009-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022266-002ONSOLISEQ 0.4MG BASEFILM / BUCCAL2009-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022266-003ONSOLISEQ 0.6MG BASEFILM / BUCCAL2009-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022266-004ONSOLISEQ 0.8MG BASEFILM / BUCCAL2009-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022266-005ONSOLISEQ 1.2MG BASEFILM / BUCCAL2009-07-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N022266-001ONSOLISEQ 0.2MG BASEFILM / BUCCAL2009-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022266-002ONSOLISEQ 0.4MG BASEFILM / BUCCAL2009-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022266-003ONSOLISEQ 0.6MG BASEFILM / BUCCAL2009-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022266-004ONSOLISEQ 0.8MG BASEFILM / BUCCAL2009-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022266-005ONSOLISEQ 1.2MG BASEFILM / BUCCAL2009-07-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022266-001ONSOLISEQ 0.2MG BASEFILM / BUCCAL2009-07-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022266-002ONSOLISEQ 0.4MG BASEFILM / BUCCAL2009-07-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022266-003ONSOLISEQ 0.6MG BASEFILM / BUCCAL2009-07-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022266-004ONSOLISEQ 0.8MG BASEFILM / BUCCAL2009-07-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022266-005ONSOLISEQ 1.2MG BASEFILM / BUCCAL2009-07-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022266-001ONSOLISEQ 0.2MG BASEFILM / BUCCAL2009-07-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022266-002ONSOLISEQ 0.4MG BASEFILM / BUCCAL2009-07-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022266-003ONSOLISEQ 0.6MG BASEFILM / BUCCAL2009-07-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022266-004ONSOLISEQ 0.8MG BASEFILM / BUCCAL2009-07-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022266-005ONSOLISEQ 1.2MG BASEFILM / BUCCAL2009-07-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022266-001ONSOLISEQ 0.2MG BASEFILM / BUCCAL2009-07-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022266-002ONSOLISEQ 0.4MG BASEFILM / BUCCAL2009-07-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022266-003ONSOLISEQ 0.6MG BASEFILM / BUCCAL2009-07-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022266-004ONSOLISEQ 0.8MG BASEFILM / BUCCAL2009-07-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022266-005ONSOLISEQ 1.2MG BASEFILM / BUCCAL2009-07-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022266-001ONSOLISEQ 0.2MG BASEFILM / BUCCAL2009-07-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022266-002ONSOLISEQ 0.4MG BASEFILM / BUCCAL2009-07-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022266-003ONSOLISEQ 0.6MG BASEFILM / BUCCAL2009-07-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022266-004ONSOLISEQ 0.8MG BASEFILM / BUCCAL2009-07-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022266-005ONSOLISEQ 1.2MG BASEFILM / BUCCAL2009-07-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022266-001ONSOLISEQ 0.2MG BASEFILM / BUCCAL2009-07-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022266-002ONSOLISEQ 0.4MG BASEFILM / BUCCAL2009-07-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022266-003ONSOLISEQ 0.6MG BASEFILM / BUCCAL2009-07-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022266-004ONSOLISEQ 0.8MG BASEFILM / BUCCAL2009-07-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022266-005ONSOLISEQ 1.2MG BASEFILM / BUCCAL2009-07-165bbf6a4d5a75…

Observed Orange Book patent history#

Patent history page 1 of 6 · 235 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022266-00195972882027-07-23U-767Drug product2017-04-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022266-00295972882027-07-23U-767Drug product2017-04-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022266-00395972882027-07-23U-767Drug product2017-04-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022266-00495972882027-07-23U-767Drug product2017-04-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022266-00595972882027-07-23U-767Drug product2017-04-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022266-00195972882027-07-23U-767Drug product2017-04-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022266-00295972882027-07-23U-767Drug product2017-04-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022266-00395972882027-07-23U-767Drug product2017-04-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022266-00495972882027-07-23U-767Drug product2017-04-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022266-00595972882027-07-23U-767Drug product2017-04-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N022266-00195972882027-07-23U-767Drug product2017-04-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022266-00295972882027-07-23U-767Drug product2017-04-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022266-00395972882027-07-23U-767Drug product2017-04-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022266-00495972882027-07-23U-767Drug product2017-04-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022266-00595972882027-07-23U-767Drug product2017-04-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022266-00195972882027-07-23U-767Drug product2017-04-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022266-00295972882027-07-23U-767Drug product2017-04-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022266-00395972882027-07-23U-767Drug product2017-04-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022266-00495972882027-07-23U-767Drug product2017-04-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022266-00595972882027-07-23U-767Drug product2017-04-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022266-00195972882027-07-23U-767Drug product2017-04-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022266-00295972882027-07-23U-767Drug product2017-04-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022266-00395972882027-07-23U-767Drug product2017-04-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022266-00495972882027-07-23U-767Drug product2017-04-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022266-00595972882027-07-23U-767Drug product2017-04-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022266-00195972882027-07-23U-767Drug product2017-04-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022266-00295972882027-07-23U-767Drug product2017-04-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022266-00395972882027-07-23U-767Drug product2017-04-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022266-00495972882027-07-23U-767Drug product2017-04-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022266-00595972882027-07-23U-767Drug product2017-04-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022266-00195972882027-07-23U-767Drug product2017-04-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022266-00295972882027-07-23U-767Drug product2017-04-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022266-00395972882027-07-23U-767Drug product2017-04-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022266-00495972882027-07-23U-767Drug product2017-04-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022266-00595972882027-07-23U-767Drug product2017-04-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022266-00195972882027-07-23U-767Drug product2017-04-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022266-00295972882027-07-23U-767Drug product2017-04-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022266-00395972882027-07-23U-767Drug product2017-04-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022266-00495972882027-07-23U-767Drug product2017-04-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022266-00595972882027-07-23U-767Drug product2017-04-035bbf6a4d5a75…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FENTANYL CITRATEFENTANYL CITRATEHospira, Inc.1ed25b2c-334e-4021-ada1-3396f07630dc2026-04-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FENTANYL CITRATE
Fentanyl CitrateFENTANYL CITRATEHikma Pharmaceuticals USA Inc.ce5db1c2-feb1-4ad2-847a-d02e865bd47e2026-03-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FENTANYL CITRATE
Fentanyl CitrateFENTANYL CITRATEHospira, Inc.bfa8018a-4cbc-434b-e09e-782872b0340a2026-02-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FENTANYL CITRATE
Fentanyl CitrateFENTANYL CITRATETeva Pharmaceuticals USA, Inc.78221eab-66fd-4cd8-9c81-af52eb83671c2026-01-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FENTANYL CITRATE
Fentanyl CitrateFENTANYL CITRATECivica, Inc.aacf276b-e133-4199-ad3f-67b894744c042025-12-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FENTANYL CITRATE
Fentanyl CitrateFENTANYL CITRATEPhlow Corp.58dcd3f7-e3d8-4929-a186-8f680a51ff112025-12-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FENTANYL CITRATE
Fentanyl CitrateFENTANYL CITRATEHikma Pharmaceuticals USA Inc.c5fcdcbd-1dd1-4ebf-aa0d-edfe845414b72025-12-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FENTANYL CITRATE
Fentanyl CitrateFENTANYL CITRATEFresenius Kabi USA, LLC0c10e465-4117-48ba-a454-23ccb7a3fcc72025-09-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FENTANYL CITRATE
Fentanyl CitrateFENTANYL CITRATEFresenius Kabi USA, LLC38d0c14a-a0c1-44cc-a939-0304eb8037d62024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FENTANYL CITRATE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71841SUPPL2022-08-18
69495SUPPL2021-12-07
66605SUPPL2021-03-08
66604SUPPL2021-03-08
66557SUPPL2021-03-05
65766SUPPL2020-12-28
60492SUPPL2019-10-09
60491SUPPL2019-10-09
60441SUPPL2019-10-09
49713SUPPL2017-09-11
46345SUPPL2016-12-21
46344SUPPL2016-12-21
46298SUPPL2016-12-20
46297SUPPL2016-12-20
38469SUPPL2015-08-12
38468SUPPL2015-01-09
29497SUPPL2014-12-30
7136SUPPL2013-11-08
17171SUPPL2012-06-11
7135SUPPL2012-06-07
29496SUPPL2012-01-03
24020ORIG2011-12-30
38467SUPPL2011-12-28
44178ORIG2011-12-22
38466SUPPL2010-07-12
29495SUPPL2010-07-08
44721ORIG2009-11-05
42474ORIG2009-11-05
29494ORIG2009-07-17
24022ORIG2009-07-17
24021ORIG2009-07-17
17170ORIG2009-07-17