Registrants (1)
Aspen Global Inc.
850491625
Manufacturing Establishments (1)
Sunrise Pharmaceutical Inc.
Par Pharmaceutical, Inc.
Aspen Global Inc.
168522378
Products (3)
Benztropine Mesylate
0603-2439
ANDA204713
ANDA (C73584)
ORAL
March 27, 2023
BenzatropineActive
Code: WMJ8TL7510Class: ACTIBQuantity: 2 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
Benztropine Mesylate
0603-2438
ANDA204713
ANDA (C73584)
ORAL
March 27, 2023
BenzatropineActive
Code: WMJ8TL7510Class: ACTIBQuantity: 1 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
Benztropine Mesylate
0603-2437
ANDA204713
ANDA (C73584)
ORAL
March 27, 2023
BenzatropineActive
Code: WMJ8TL7510Class: ACTIBQuantity: 0.5 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT