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FDA Approval

Acitretin

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

FDA Approval Summary

Company
Effective Date
December 20, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Acitretin(10 mg in 1 1)

Products2

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

Acitretin

Product Details

NDC Product Code
0378-7020
Application Number
ANDA202148
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 15, 2022
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
AcitretinActive
Code: LCH760E9T7Class: ACTIBQuantity: 10 mg in 1 1
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMKClass: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
SODIUM ASCORBATEInactive
Code: S033EH8359Class: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT

Acitretin

Product Details

NDC Product Code
0378-7023
Application Number
ANDA202148
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 15, 2022
AcitretinActive
Code: LCH760E9T7Class: ACTIBQuantity: 25 mg in 1 1
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMKClass: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
SODIUM ASCORBATEInactive
Code: S033EH8359Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
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