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Glycopyrrolate Oral Solution

Glycopyrrolate Oral Solution 1 mg/5 mL

Approved
Approval ID

e20c9a89-2a81-3c6e-e053-2995a90a9861

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 9, 2024

Manufacturers
FDA

Taro Pharmaceuticals U.S.A. Inc.

DUNS: 145186370

Products 1

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

Glycopyrrolate Oral Solution

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51672-5316
Application NumberANDA212467
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glycopyrrolate Oral Solution
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification

INGREDIENTS (1)

GLYCOPYRROLATEActive
Quantity: 1 mg in 5 mL
Code: V92SO9WP2I
Classification: ACTIB

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