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FDA Approval

Methimazole

CompanyState of Florida DOH Central Pharmacy (DUNS: 829348114)

Effective Date

September 25, 2013

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Methimazole(10 mg in 1 1)

Manufacturing Establishments (1)

State of Florida DOH Central Pharmacy

Labeler

State of Florida DOH Central Pharmacy

DUNS Number

829348114

Products (1)

Methimazole

NDC Product Code

53808-0850

Application Number

ANDA040350

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 25, 2013

Ingredients

MethimazoleActive

Code: 554Z48XN5EClass: ACTIBQuantity: 10 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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