Registrants (1)
Chartwell RX Sciences, LLC
081464659
Manufacturing Establishments (1)
Chartwell Pharmaceuticals Congers, LLC
Chartwell RX, LLC
Chartwell RX Sciences, LLC
118673447
Products (2)
Methimazole
62135-206
ANDA040411
ANDA (C73584)
ORAL
December 12, 2022
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MethimazoleActive
Code: 554Z48XN5EClass: ACTIBQuantity: 10 mg in 1 1
TALCInactive
Code: 7SEV7J4R1UClass: IACT
Methimazole
62135-205
ANDA040411
ANDA (C73584)
ORAL
December 12, 2022
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MethimazoleActive
Code: 554Z48XN5EClass: ACTIBQuantity: 5 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT