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Pyridostigmine Bromide

Pyridostigmine Bromide Tablets, USP (30 mg) Rx only

Approved
Approval ID

91ca7bcf-d2cc-4cb3-bfbe-c294fd707524

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 31, 2023

Manufacturers
FDA

Amneal Pharmaceuticals of New York LLC

DUNS: 123797875

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

PYRIDOSTIGMINE BROMIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0115-2134
Application NumberANDA040502
Product Classification
M
Marketing Category
C73584
G
Generic Name
PYRIDOSTIGMINE BROMIDE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 31, 2023
FDA Product Classification

INGREDIENTS (5)

PYRIDOSTIGMINE BROMIDEActive
Quantity: 30 mg in 1 1
Code: KVI301NA53
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT

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Pyridostigmine Bromide - FDA Drug Approval Details