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FDA Approval

Pyridostigmine Bromide

CompanyAmneal Pharmaceuticals of New York LLC (DUNS: 123797875)

Effective Date

January 31, 2019

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Pyridostigmine(180 mg in 1 1)

Manufacturing Establishments (2)

Amneal Pharmaceuticals of New York, LLC

Labeler

Amneal Pharmaceuticals of New York LLC

DUNS Number

123797875

Amneal Pharmaceuticals, LLC

Labeler

Amneal Pharmaceuticals of New York LLC

DUNS Number

969951594

Products (1)

Pyridostigmine Bromide

NDC Product Code

0115-1404

Application Number

ANDA203184

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 31, 2019

Ingredients

PyridostigmineActive

Code: KVI301NA53Class: ACTIBQuantity: 180 mg in 1 1

CARNAUBA WAXInactive

Code: R12CBM0EIZClass: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

COPOVIDONE K25-31Inactive

Code: D9C330MD8BClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

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