Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
G Production Inc.
Galderma Laboratories, L.P.
251676961
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
EPIDUO
Product Details
NDC Product Code
0299-5908Application Number
NDA022320Marketing Category
NDA (C73594)Route of Administration
TOPICALEffective Date
February 19, 2018poloxamer 124Inactive
Code: 1S66E28KXAClass: IACT
propylene glycolInactive
Code: 6DC9Q167V3Class: IACT
AdapaleneActive
Code: 1L4806J2QFClass: ACTIBQuantity: 1 mg in 1 g
Benzoyl peroxideActive
Code: W9WZN9A0GMClass: ACTIBQuantity: 25 mg in 1 g
glycerinInactive
Code: PDC6A3C0OXClass: IACT
docusate sodiumInactive
Code: F05Q2T2JA0Class: IACT
edetate disodiumInactive
Code: 7FLD91C86KClass: IACT
IsohexadecaneInactive
Code: 918X1OUF1EClass: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
WaterInactive
Code: 059QF0KO0RClass: IACT
Sorbitan MonooleateInactive
Code: 06XEA2VD56Class: IACT