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FDA Approval

Adapalene

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
DUNS: 043838424
Effective Date
August 18, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Adapalene(1 mg in 1 g)

Products1

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

Adapalene

Product Details

NDC Product Code
0168-0424
Application Number
ANDA090824
Marketing Category
ANDA (C73584)
Route of Administration
TOPICAL
Effective Date
August 22, 2018
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Inactive
Code: Z135WT9208Class: IACT
AdapaleneActive
Code: 1L4806J2QFClass: ACTIBQuantity: 1 mg in 1 g
CYCLOMETHICONEInactive
Code: NMQ347994ZClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3TClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SQUALENEInactive
Code: 7QWM220FJHClass: IACT
TROLAMINEInactive
Code: 9O3K93S3TKClass: IACT
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