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FDA Approval

Methimazole

CompanyBryant Ranch Prepack (DUNS: 171714327)

Effective Date

February 17, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Methimazole(5 mg in 1 1)

Registrants (1)

Bryant Ranch Prepack

DUNS Number

171714327

Manufacturing Establishments (1)

Bryant Ranch Prepack

Labeler

Bryant Ranch Prepack

Registrant

Bryant Ranch Prepack

DUNS Number

171714327

Products (1)

Methimazole

NDC Product Code

63629-9250

Application Number

ANDA040350

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 28, 2022

Ingredients

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MethimazoleActive

Code: 554Z48XN5EClass: ACTIBQuantity: 5 mg in 1 1

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

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