MedPath
FDA Approval

AMAZON BASIC CARE NICOTINE POLACRILEX

May 2, 2025

Human OTC Drug Label

Nicotine(2 mg in 1 1)

Registrants (1)

Aurohealth LLC

078728447

Manufacturing Establishments (1)

APL HEALTHCARE LIMITED

Amazon.com Services LLC

Aurohealth LLC

650918514

Products (1)

AMAZON BASIC CARE NICOTINE POLACRILEX

72288-623

ANDA213266

ANDA (C73584)

ORAL

May 2, 2025

CORN SYRUPInactive
Code: 9G5L16BK6NClass: IACT
ICODEXTRINInactive
Code: 2NX48Z0A9GClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive
Code: 461P5CJN6TClass: IACT
POTASSIUM BICARBONATEInactive
Code: HM5Z15LEBNClass: IACT
SODIUM ALGINATEInactive
Code: C269C4G2ZQClass: IACT
NicotineActive
Code: 6M3C89ZY6RClass: ACTIBQuantity: 2 mg in 1 1
ASPARTAMEInactive
Code: Z0H242BBR1Class: IACT
CALCIUM POLYCARBOPHILInactive
Code: 8F049NKY49Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7TClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
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