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SILDENAFIL CITRATE

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

78c4551c-b922-43c9-9a5a-66377ea07bc2

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 25, 2023

Manufacturers
FDA

PD-Rx Pharmaceuticals, Inc.

DUNS: 156893695

Products 1

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 Code43063-941
Application NumberANDA091448
Product Classification
M
Marketing Category
C73584
G
Generic Name
SILDENAFIL
Product Specifications
Route of AdministrationORAL
Effective DateApril 25, 2023
FDA Product Classification

INGREDIENTS (9)

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SILDENAFIL CITRATEActive
Quantity: 50 mg in 1 1
Code: BW9B0ZE037
Classification: ACTIM
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT

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SILDENAFIL CITRATE - FDA Drug Approval Details