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FDA Approval

Sildenafil

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

FDA Approval Summary

Company
Reyoung Corporation
DUNS: 118009917
Effective Date
April 14, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Sildenafil(100 mg in 1 1)

Products3

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

Sildenafil

Product Details

NDC Product Code
82647-212
Application Number
ANDA208494
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 14, 2022
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7UClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
Code: BW9B0ZE037Class: ACTIMQuantity: 100 mg in 1 1

Sildenafil

Product Details

NDC Product Code
82647-210
Application Number
ANDA208494
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 14, 2022
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
Code: BW9B0ZE037Class: ACTIMQuantity: 25 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7UClass: IACT

Sildenafil

Product Details

NDC Product Code
82647-211
Application Number
ANDA208494
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 14, 2022
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7UClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Code: BW9B0ZE037Class: ACTIMQuantity: 50 mg in 1 1
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