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FDA Approval

Differin

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

FDA Approval Summary

Company
Effective Date
January 21, 2011
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Adapalene(1 mg in 1 g)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Physicians Total Care, Inc.

Physicians Total Care, Inc.

194123980

Products1

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

Differin

Product Details

NDC Product Code
54868-5271
Application Number
NDA020748
Marketing Category
NDA (C73594)
Route of Administration
TOPICAL
Effective Date
January 21, 2011
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
AdapaleneActive
Code: 1L4806J2QFClass: ACTIBQuantity: 1 mg in 1 g
SQUALANEInactive
Code: GW89575KF9Class: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3TClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
TROLAMINEInactive
Code: 9O3K93S3TKClass: IACT
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Differin - FDA Approval | MedPath