MedPath

Clindamycin Phosphate and Tretinoin

These highlights do not include all the information needed to use CLINDAMYCIN PHOSPHATE AND TRETINOIN GEL safely and effectively. See full prescribing information for CLINDAMYCIN PHOSPHATE AND TRETINOIN GEL. CLINDAMYCIN PHOSPAHTE AND TRETINOIN gel, for topical use only Initial U.S. Approval: 2006

Approved
Approval ID

c3ad6c2d-d106-464d-8e27-67ae94793e88

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 18, 2023

Manufacturers
FDA

Solaris Pharma Corporation

DUNS: 079904672

Products 1

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

clindamycin phosphate and tretinoin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code73473-306
Application NumberANDA212845
Product Classification
M
Marketing Category
C73584
G
Generic Name
clindamycin phosphate and tretinoin
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 18, 2023
FDA Product Classification

INGREDIENTS (2)

CLINDAMYCIN PHOSPHATEActive
Quantity: 10 mg in 1 g
Code: EH6D7113I8
Classification: ACTIM
TRETINOINActive
Quantity: 0.25 mg in 1 g
Code: 5688UTC01R
Classification: ACTIB

MedPath

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

© 2025 MedPath, Inc. All rights reserved.

Clindamycin Phosphate and Tretinoin - FDA Drug Approval Details