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SILDENAFIL

These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998

Approved
Approval ID

e671d887-2317-4c1c-9b68-e24cda3d3aef

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 8, 2021

Manufacturers
FDA

Advagen Pharma Ltd

DUNS: 051627256

Products 3

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

sildenafil

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72888-017
Application NumberANDA204882
Product Classification
M
Marketing Category
C73584
G
Generic Name
sildenafil
Product Specifications
Route of AdministrationORAL
Effective DateNovember 8, 2021
FDA Product Classification

INGREDIENTS (10)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILDENAFIL CITRATEActive
Quantity: 100 mg in 1 1
Code: BW9B0ZE037
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT

sildenafil

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72888-016
Application NumberANDA204882
Product Classification
M
Marketing Category
C73584
G
Generic Name
sildenafil
Product Specifications
Route of AdministrationORAL
Effective DateNovember 8, 2021
FDA Product Classification

INGREDIENTS (10)

CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SILDENAFIL CITRATEActive
Quantity: 50 mg in 1 1
Code: BW9B0ZE037
Classification: ACTIM

sildenafil

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72888-015
Application NumberANDA204882
Product Classification
M
Marketing Category
C73584
G
Generic Name
sildenafil
Product Specifications
Route of AdministrationORAL
Effective DateNovember 8, 2021
FDA Product Classification

INGREDIENTS (10)

CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SILDENAFIL CITRATEActive
Quantity: 25 mg in 1 1
Code: BW9B0ZE037
Classification: ACTIM

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SILDENAFIL - FDA Drug Approval Details