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FDA Approval

pyridostigmine bromide

CompanyMajor Pharmaceuticals (DUNS: 191427277)

Effective Date

December 14, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Pyridostigmine(60 mg in 1 1)

Products (1)

pyridostigmine bromide

NDC Product Code

0904-6622

Application Number

ANDA205650

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 4, 2017

Ingredients

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

PyridostigmineActive

Code: KVI301NA53Class: ACTIBQuantity: 60 mg in 1 1

LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 2165RE0K14Class: IACT

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