Liqrev
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 1998
Approved
Approval ID
13fb930a-fc46-4e0d-8d05-39162c156714
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 30, 2023
Manufacturers
FDA
CMP Pharma, Inc.
DUNS: 005224175
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 Code46287-055
Application NumberNDA214952
Product Classification
M
Marketing Category
C73594
G
Generic Name
sildenafil
Product Specifications
Route of AdministrationORAL
Effective DateApril 30, 2023
FDA Product Classification
INGREDIENTS (10)
SILDENAFIL CITRATEActive
Quantity: 10 mg in 1 mL
Code: BW9B0ZE037
Classification: ACTIM
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT