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adapalene and benzoyl peroxide

These highlights do not include all the information needed to use ADAPALENE AND BENZOYL PEROXIDE GEL safely and effectively. See full prescribing information for ADAPALENE AND BENZOYL PEROXIDE GEL. ADAPALENE AND BENZOYL PEROXIDE Gel, for topical useInitial U.S. Approval: 2008

Approved
Approval ID

fc8e868f-9699-4ae6-83d5-fa27789336cd

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 30, 2020

Manufacturers
FDA

Glenmark Pharmaceuticals Inc., USA

DUNS: 130597813

Products 1

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

adapalene and benzoyl peroxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68462-301
Application NumberANDA208108
Product Classification
M
Marketing Category
C73584
G
Generic Name
adapalene and benzoyl peroxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 30, 2020
FDA Product Classification

INGREDIENTS (12)

BENZOYL PEROXIDEActive
Quantity: 25 mg in 1 g
Code: W9WZN9A0GM
Classification: ACTIB
ADAPALENEActive
Quantity: 1 mg in 1 g
Code: 1L4806J2QF
Classification: ACTIB
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
CYCLOMETHICONEInactive
Code: NMQ347994Z
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLOXAMER 124Inactive
Code: 1S66E28KXA
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

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adapalene and benzoyl peroxide - FDA Drug Approval Details