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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
AvKARE
DUNS: 796560394
Effective Date
January 9, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Acitretin(10 mg in 1 1)

Products3

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
42291-086
Application Number
ANDA204633
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 9, 2024
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SODIUM ASCORBATEInactive
Code: S033EH8359Class: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
AcitretinActive
Code: LCH760E9T7Class: ACTIBQuantity: 10 mg in 1 1

ACITRETIN

Product Details

NDC Product Code
42291-087
Application Number
ANDA204633
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 9, 2024
SODIUM ASCORBATEInactive
Code: S033EH8359Class: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
AcitretinActive
Code: LCH760E9T7Class: ACTIBQuantity: 17.5 mg in 1 1
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT

ACITRETIN

Product Details

NDC Product Code
42291-088
Application Number
ANDA204633
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 9, 2024
SODIUM ASCORBATEInactive
Code: S033EH8359Class: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
AcitretinActive
Code: LCH760E9T7Class: ACTIBQuantity: 25 mg in 1 1
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
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