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FDA Approval

Pyridostigmine Bromide

CompanyAmneal Pharmaceuticals of New York LLC (DUNS: 123797875)

Effective Date

December 31, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Pyridostigmine(30 mg in 1 1)

Manufacturing Establishments (1)

Amneal Pharmaceuticals of New York, LLC

Labeler

Amneal Pharmaceuticals of New York LLC

DUNS Number

123797875

Products (1)

Pyridostigmine Bromide

NDC Product Code

0115-2134

Application Number

ANDA040502

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 31, 2023

Ingredients

PyridostigmineActive

Code: KVI301NA53Class: ACTIBQuantity: 30 mg in 1 1

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

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