MedPath
FDA Approval

Methimazole

August 2, 2023

HUMAN PRESCRIPTION DRUG LABEL

Methimazole(5 mg in 1 1)

Registrants (1)

Preferred Pharmaceuticals Inc.

791119022

Manufacturing Establishments (1)

Preferred Pharmaceuticals Inc.

Preferred Pharmaceuticals Inc.

Preferred Pharmaceuticals Inc.

791119022

Products (1)

Methimazole

68788-8226

ANDA040734

ANDA (C73584)

ORAL

August 2, 2023

Code: 554Z48XN5EClass: ACTIBQuantity: 5 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
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