Tretinoin
These highlights do not include all the information needed to use CAPSULES safely and effectively. See full prescribing information for . for oral use Initial U.S. Approval: 1995
Approved
Approval ID
9c4ae9d9-c2a0-4995-a27a-e3f0f0284db9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 20, 2023
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tretinoin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10370-268
Application NumberANDA201687
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tretinoin
Product Specifications
Route of AdministrationORAL
Effective DateApril 13, 2023
FDA Product Classification
INGREDIENTS (14)
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TRETINOINActive
Quantity: 10 mg in 1 1
Code: 5688UTC01R
Classification: ACTIB
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT