Sildenafil
These highlights do not include all the information needed to use SILDENAFIL FOR ORAL SUSPENSION safely and effectively. See full prescribing information for SILDENAFIL FOR ORAL SUSPENSION. SILDENAFIL for oral suspension Initial U.S. Approval: 1998
Approved
Approval ID
283790ed-2acb-4714-a0af-b348bb642785
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2023
Manufacturers
FDA
Ajanta Pharma USA Inc.
DUNS: 557554156
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 Code27241-175
Application NumberANDA212883
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sildenafil
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2023
FDA Product Classification
INGREDIENTS (10)
SILDENAFIL CITRATEActive
Quantity: 10 mg in 1 mL
Code: BW9B0ZE037
Classification: ACTIM
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT