MedPath
FDA Approval

Methimazole

May 3, 2022

HUMAN PRESCRIPTION DRUG LABEL

Methimazole(5 mg in 1 1)

Manufacturing Establishments (1)

Par Pharmaceutical Inc.

Par Pharmaceutical, Inc.

092733690

Products (2)

Methimazole

49884-640

ANDA040350

ANDA (C73584)

ORAL

May 3, 2022

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

Methimazole

49884-641

ANDA040350

ANDA (C73584)

ORAL

May 3, 2022

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