BRIXADI

Registrants (1)

Braeburn Inc.

DUNS Number

078763433

Products (7)

NDC Product Code

58284-208

Application Number

NDA210136

Marketing Category

NDA (C73594)

Route of Administration

SUBCUTANEOUS

Effective Date

June 6, 2023

Ingredients

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

GLYCERYL DIOLEATEInactive

Code: Z3MP1W91CWClass: IACT

BuprenorphineActive

Code: 40D3SCR4GZClass: ACTIBQuantity: 8 mg in 0.16 mL

LECITHIN, SOYBEANInactive

Code: 1DI56QDM62Class: IACT

BRIXADI

NDC Product Code

58284-232

Application Number

NDA210136

Marketing Category

NDA (C73594)

Route of Administration

SUBCUTANEOUS

Effective Date

June 6, 2023

Ingredients

BuprenorphineActive

Code: 40D3SCR4GZClass: ACTIBQuantity: 32 mg in 0.64 mL

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

LECITHIN, SOYBEANInactive

Code: 1DI56QDM62Class: IACT

GLYCERYL DIOLEATEInactive

Code: Z3MP1W91CWClass: IACT

BRIXADI

NDC Product Code

58284-216

Application Number

NDA210136

Marketing Category

NDA (C73594)

Route of Administration

SUBCUTANEOUS

Effective Date

June 6, 2023

Ingredients

LECITHIN, SOYBEANInactive

Code: 1DI56QDM62Class: IACT

BuprenorphineActive

Code: 40D3SCR4GZClass: ACTIBQuantity: 16 mg in 0.32 mL

GLYCERYL DIOLEATEInactive

Code: Z3MP1W91CWClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

BRIXADI

NDC Product Code

58284-228

Application Number

NDA210136

Marketing Category

NDA (C73594)

Route of Administration

SUBCUTANEOUS

Effective Date

June 6, 2023

Ingredients

LECITHIN, SOYBEANInactive

Code: 1DI56QDM62Class: IACT

GLYCERYL DIOLEATEInactive

Code: Z3MP1W91CWClass: IACT

BuprenorphineActive

Code: 40D3SCR4GZClass: ACTIBQuantity: 128 mg in 0.36 mL

METHYLPYRROLIDONEInactive

Code: JR9CE63FPMClass: IACT

BRIXADI

NDC Product Code

58284-296

Application Number

NDA210136

Marketing Category

NDA (C73594)

Route of Administration

SUBCUTANEOUS

Effective Date

June 6, 2023

Ingredients

BuprenorphineActive

Code: 40D3SCR4GZClass: ACTIBQuantity: 96 mg in 0.27 mL

METHYLPYRROLIDONEInactive

Code: JR9CE63FPMClass: IACT

LECITHIN, SOYBEANInactive

Code: 1DI56QDM62Class: IACT

GLYCERYL DIOLEATEInactive

Code: Z3MP1W91CWClass: IACT

BRIXADI

NDC Product Code

58284-224

Application Number

NDA210136

Marketing Category

NDA (C73594)

Route of Administration

SUBCUTANEOUS

Effective Date

June 6, 2023

Ingredients

LECITHIN, SOYBEANInactive

Code: 1DI56QDM62Class: IACT

BuprenorphineActive

Code: 40D3SCR4GZClass: ACTIBQuantity: 24 mg in 0.48 mL

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

GLYCERYL DIOLEATEInactive

Code: Z3MP1W91CWClass: IACT

BRIXADI

NDC Product Code

58284-264

Application Number

NDA210136

Marketing Category

NDA (C73594)

Route of Administration

SUBCUTANEOUS

Effective Date

June 6, 2023

Ingredients

BuprenorphineActive

Code: 40D3SCR4GZClass: ACTIBQuantity: 64 mg in 0.18 mL

LECITHIN, SOYBEANInactive

Code: 1DI56QDM62Class: IACT

METHYLPYRROLIDONEInactive

Code: JR9CE63FPMClass: IACT

GLYCERYL DIOLEATEInactive

Code: Z3MP1W91CWClass: IACT

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BRIXADI

Registrants (1)

Products (7)

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