FDA.reportPublic FDA data

Application 210136

Type
NDA
Sponsor
BRAEBURN PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BRIXADIBUPRENORPHINEINJECTION, EXTENDED RELEASE;SUBCUTANEOUS8MGNoNo
002BRIXADIBUPRENORPHINESOLUTION, EXTENDED RELEASE;SUBCUTANEOUS16MG/0.32ML (50MG/ML)YesYes
003BRIXADIBUPRENORPHINESOLUTION, EXTENDED RELEASE;SUBCUTANEOUS24MG/0.48ML (50MG/ML)YesYes
004BRIXADIBUPRENORPHINESOLUTION, EXTENDED RELEASE;SUBCUTANEOUS32MG/0.64ML (50MG/ML)YesYes
005BRIXADIBUPRENORPHINESOLUTION, EXTENDED RELEASE;SUBCUTANEOUS64MG/0.18ML (356MG/ML)YesYes
006BRIXADIBUPRENORPHINESOLUTION, EXTENDED RELEASE;SUBCUTANEOUS96MG/0.27ML (356MG/ML)YesYes
007BRIXADIBUPRENORPHINESOLUTION, EXTENDED RELEASE;SUBCUTANEOUS128MG/0.36ML (356MG/ML)YesYes

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

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N210136-001BRIXADIBUPRENORPHINE8MG/0.16ML (50MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD, RS2023-05-23
N210136-002BRIXADIBUPRENORPHINE16MG/0.32ML (50MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD, RS2023-05-23
N210136-003BRIXADIBUPRENORPHINE24MG/0.48ML (50MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD, RS2023-05-23
N210136-004BRIXADIBUPRENORPHINE32MG/0.64ML (50MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD, RS2023-05-23
N210136-005BRIXADIBUPRENORPHINE64MG/0.18ML (356MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD, RS2023-05-23
N210136-006BRIXADIBUPRENORPHINE96MG/0.27ML (356MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD, RS2023-05-23
N210136-007BRIXADIBUPRENORPHINE128MG/0.36ML (356MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD, RS2023-05-23

Orange Book patents#

Current patent rows page 1 of 1 · 56 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N210136-00182367552026-07-31U-3620Drug product2023-06-06
N210136-00182362922027-01-10U-3619Drug product2023-06-06
N210136-001109127722032-07-26U-36172023-06-06
N210136-001111100842032-07-26U-3616Drug product2023-06-06
N210136-001111352152032-07-26Drug product2023-06-06
N210136-001121616402032-07-26U-4100Drug product2025-01-08
N210136-001123183792032-07-26U-4100Drug product2025-06-30
N210136-00199371642032-07-26U-3618Drug product2023-06-06
N210136-00282367552026-07-31U-3620Drug product2023-06-06
N210136-00282362922027-01-10U-3619Drug product2023-06-06
N210136-002109127722032-07-26U-36172023-06-06
N210136-002111100842032-07-26U-3616Drug product2023-06-06
N210136-002111352152032-07-26Drug product2023-06-06
N210136-002121616402032-07-26U-4100Drug product2025-01-08
N210136-002123183792032-07-26U-4100Drug product2025-06-30
N210136-00299371642032-07-26U-3618Drug product2023-06-06
N210136-00382367552026-07-31U-3620Drug product2023-06-06
N210136-00382362922027-01-10U-3619Drug product2023-06-06
N210136-003109127722032-07-26U-36172023-06-06
N210136-003111100842032-07-26U-3616Drug product2023-06-06
N210136-003111352152032-07-26Drug product2023-06-06
N210136-003121616402032-07-26U-4100Drug product2025-01-08
N210136-003123183792032-07-26U-4100Drug product2025-06-30
N210136-00399371642032-07-26U-3618Drug product2023-06-06
N210136-00482367552026-07-31U-3620Drug product2023-06-06
N210136-00482362922027-01-10U-3619Drug product2023-06-06
N210136-004109127722032-07-26U-36172023-06-06
N210136-004111100842032-07-26U-3616Drug product2023-06-06
N210136-004111352152032-07-26Drug product2023-06-06
N210136-004121616402032-07-26U-4100Drug product2025-01-08
N210136-004123183792032-07-26U-4100Drug product2025-06-30
N210136-00499371642032-07-26U-3618Drug product2023-06-06
N210136-00582367552026-07-31U-3620Drug product2023-06-06
N210136-00582362922027-01-10U-3619Drug product2023-06-06
N210136-005109127722032-07-26U-36172023-06-06
N210136-005111100842032-07-26U-3616Drug product2023-06-06
N210136-005111352152032-07-26Drug product2023-06-06
N210136-005121616402032-07-26U-4100Drug product2025-01-08
N210136-005123183792032-07-26U-4100Drug product2025-06-30
N210136-00599371642032-07-26U-3618Drug product2023-06-06
N210136-00682367552026-07-31U-3620Drug product2023-06-06
N210136-00682362922027-01-10U-3619Drug product2023-06-06
N210136-006109127722032-07-26U-36172023-06-06
N210136-006111100842032-07-26U-3616Drug product2023-06-06
N210136-006111352152032-07-26Drug product2023-06-06
N210136-006121616402032-07-26U-4100Drug product2025-01-08
N210136-006123183792032-07-26U-4100Drug product2025-06-30
N210136-00699371642032-07-26U-3618Drug product2023-06-06
N210136-00782367552026-07-31U-3620Drug product2023-06-06
N210136-00782362922027-01-10U-3619Drug product2023-06-06
N210136-007109127722032-07-26U-36172023-06-06
N210136-007111100842032-07-26U-3616Drug product2023-06-06
N210136-007111352152032-07-26Drug product2023-06-06
N210136-007121616402032-07-26U-4100Drug product2025-01-08
N210136-007123183792032-07-26U-4100Drug product2025-06-30
N210136-00799371642032-07-26U-3618Drug product2023-06-06

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 7 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N210136-001NP2026-05-23
N210136-002NP2026-05-23
N210136-003NP2026-05-23
N210136-004NP2026-05-23
N210136-005NP2026-05-23
N210136-006NP2026-05-23
N210136-007NP2026-05-23

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 4 · 154 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N210136-001BRIXADI8MG/0.16ML (50MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-002BRIXADI16MG/0.32ML (50MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-003BRIXADI24MG/0.48ML (50MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-004BRIXADI32MG/0.64ML (50MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-005BRIXADI64MG/0.18ML (356MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-006BRIXADI96MG/0.27ML (356MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-007BRIXADI128MG/0.36ML (356MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD, RS2023-05-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210136-001BRIXADI8MG/0.16ML (50MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210136-002BRIXADI16MG/0.32ML (50MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210136-003BRIXADI24MG/0.48ML (50MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210136-004BRIXADI32MG/0.64ML (50MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210136-005BRIXADI64MG/0.18ML (356MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210136-006BRIXADI96MG/0.27ML (356MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210136-007BRIXADI128MG/0.36ML (356MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD, RS2023-05-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N210136-001BRIXADI8MG/0.16ML (50MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210136-002BRIXADI16MG/0.32ML (50MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210136-003BRIXADI24MG/0.48ML (50MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210136-004BRIXADI32MG/0.64ML (50MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210136-005BRIXADI64MG/0.18ML (356MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210136-006BRIXADI96MG/0.27ML (356MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210136-007BRIXADI128MG/0.36ML (356MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD, RS2023-05-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210136-001BRIXADI8MG/0.16ML (50MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210136-002BRIXADI16MG/0.32ML (50MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210136-003BRIXADI24MG/0.48ML (50MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210136-004BRIXADI32MG/0.64ML (50MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210136-005BRIXADI64MG/0.18ML (356MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210136-006BRIXADI96MG/0.27ML (356MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210136-007BRIXADI128MG/0.36ML (356MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD, RS2023-05-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210136-001BRIXADI8MG/0.16ML (50MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210136-002BRIXADI16MG/0.32ML (50MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210136-003BRIXADI24MG/0.48ML (50MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210136-004BRIXADI32MG/0.64ML (50MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210136-005BRIXADI64MG/0.18ML (356MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210136-006BRIXADI96MG/0.27ML (356MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210136-007BRIXADI128MG/0.36ML (356MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD, RS2023-05-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210136-001BRIXADI8MG/0.16ML (50MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210136-002BRIXADI16MG/0.32ML (50MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210136-003BRIXADI24MG/0.48ML (50MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210136-004BRIXADI32MG/0.64ML (50MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210136-005BRIXADI64MG/0.18ML (356MG/ML)SOLUTION, EXTENDED RELEASE / SUBCUTANEOUSRLD2023-05-2303ed91905a0d…

Observed Orange Book patent history#

Patent history page 1 of 29 · 1,134 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N210136-00182367552026-07-31U-3620Drug product2023-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-00182362922027-01-10U-3619Drug product2023-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-001109127722032-07-26U-36172023-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-001111100842032-07-26U-3616Drug product2023-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-001111352152032-07-26Drug product2023-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-001121616402032-07-26U-4100Drug product2025-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-001123183792032-07-26U-4100Drug product2025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-00199371642032-07-26U-3618Drug product2023-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-00282367552026-07-31U-3620Drug product2023-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-00282362922027-01-10U-3619Drug product2023-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-002109127722032-07-26U-36172023-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-002111100842032-07-26U-3616Drug product2023-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-002111352152032-07-26Drug product2023-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-002121616402032-07-26U-4100Drug product2025-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-002123183792032-07-26U-4100Drug product2025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-00299371642032-07-26U-3618Drug product2023-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-00382367552026-07-31U-3620Drug product2023-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-00382362922027-01-10U-3619Drug product2023-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-003109127722032-07-26U-36172023-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-003111100842032-07-26U-3616Drug product2023-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-003111352152032-07-26Drug product2023-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-003121616402032-07-26U-4100Drug product2025-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-003123183792032-07-26U-4100Drug product2025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-00399371642032-07-26U-3618Drug product2023-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-00482367552026-07-31U-3620Drug product2023-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-00482362922027-01-10U-3619Drug product2023-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-004109127722032-07-26U-36172023-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-004111100842032-07-26U-3616Drug product2023-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-004111352152032-07-26Drug product2023-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-004121616402032-07-26U-4100Drug product2025-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-004123183792032-07-26U-4100Drug product2025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-00499371642032-07-26U-3618Drug product2023-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-00582367552026-07-31U-3620Drug product2023-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-00582362922027-01-10U-3619Drug product2023-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-005109127722032-07-26U-36172023-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-005111100842032-07-26U-3616Drug product2023-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-005111352152032-07-26Drug product2023-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-005121616402032-07-26U-4100Drug product2025-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-005123183792032-07-26U-4100Drug product2025-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-00599371642032-07-26U-3618Drug product2023-06-06011fe1cb6892…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 140 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N210136-001NP2026-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-002NP2026-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-003NP2026-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-004NP2026-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-005NP2026-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-006NP2026-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210136-007NP2026-05-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210136-001NP2026-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210136-002NP2026-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210136-003NP2026-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210136-004NP2026-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210136-005NP2026-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210136-006NP2026-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210136-007NP2026-05-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N210136-001NP2026-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210136-002NP2026-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210136-003NP2026-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210136-004NP2026-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210136-005NP2026-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210136-006NP2026-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210136-007NP2026-05-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210136-001NP2026-05-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210136-002NP2026-05-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210136-003NP2026-05-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210136-004NP2026-05-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210136-005NP2026-05-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210136-006NP2026-05-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210136-007NP2026-05-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210136-001NP2026-05-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210136-002NP2026-05-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210136-003NP2026-05-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210136-004NP2026-05-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210136-005NP2026-05-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210136-006NP2026-05-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210136-007NP2026-05-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210136-001NP2026-05-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210136-002NP2026-05-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210136-003NP2026-05-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210136-004NP2026-05-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210136-005NP2026-05-2303ed91905a0d…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BRIXADIBUPRENORPHINEBraeburn Inc.5d8a8fd0-8619-422a-a664-d1d2e8970f482025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 210136
application number: NDA210136

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85203SUPPL 2026-03-02
84642SUPPL 2026-01-05
84585SUPPL 2025-12-29
83284SUPPL 2025-09-04
81895SUPPL 2025-04-09
77924ORIG 2024-03-25
77049SUPPL 2023-12-19
77044SUPPL 2023-12-19
74355ORIG 2023-11-06
74358ORIG 2023-05-23
74357ORIG 2023-05-23
57788ORIG2019-02-22