PANRETIN
Panretin gel Panretin® (alitretinoin) gel 0.1% (For topical use only) Rx only
Approved
Approval ID
49c16717-7d86-4257-80c9-baa1417e5555
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 18, 2021
Manufacturers
FDA
Concordia Pharmaceuticals Inc.
DUNS: 815240092
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
alitretinoin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59212-601
Application NumberNDA020886
Product Classification
M
Marketing Category
C73594
G
Generic Name
alitretinoin
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 10, 2019
FDA Product Classification
INGREDIENTS (5)
ALITRETINOINActive
Quantity: 60 mg in 60 g
Code: 1UA8E65KDZ
Classification: ACTIB
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT