MedPath

Clindamycin Phosphate

Clindamycin Phosphate Topical Solution, USP 1%

Approved
Approval ID

ae7f006e-baba-4fb2-8329-35960eeaca89

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 9, 2024

Manufacturers
FDA

Glasshouse Pharmaceuticals Limited Canada

DUNS: 203493598

Products 1

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

Clindamycin Phosphate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71428-003
Application NumberANDA209846
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clindamycin Phosphate
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 9, 2024
FDA Product Classification

INGREDIENTS (5)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
CLINDAMYCINActive
Quantity: 10 mg in 1 mL
Code: 3U02EL437C
Classification: ACTIB

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Clindamycin Phosphate - FDA Drug Approval Details