BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Seton Pharmaceuticals LLC

DUNS Number

828898002

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Product Details

NDC Product Code

13925-536

Application Number

ANDA214087

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 22, 2022

Ingredients

ButalbitalActive

Code: KHS0AZ4JVKClass: ACTIBQuantity: 50 mg in 1 1

AcetaminophenActive

Code: 362O9ITL9DClass: ACTIBQuantity: 325 mg in 1 1

CaffeineActive

Code: 3G6A5W338EClass: ACTIBQuantity: 40 mg in 1 1

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT