MedPath
FDA Approval

Methimazole

August 11, 2023

HUMAN PRESCRIPTION DRUG LABEL

Methimazole(10 mg in 1 1)

Registrants (1)

Bryant Ranch Prepack

171714327

Manufacturing Establishments (1)

Bryant Ranch Prepack

Bryant Ranch Prepack

Bryant Ranch Prepack

171714327

Products (1)

Methimazole

63629-2224

ANDA040350

ANDA (C73584)

ORAL

August 11, 2023

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
Code: 554Z48XN5EClass: ACTIBQuantity: 10 mg in 1 1

Drug Labeling Information

CONTRAINDICATIONS SECTION

CONTRAINDICATIONS

Methimazole is contraindicated in the presence of hypersensitivity to the drug or any of the other product components.


HOW SUPPLIED SECTION

HOW SUPPLIED

NDC: 63629-2224-1: 100 Tablets in a BOTTLE


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