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FDA Approval

Sildenafil

CompanyUnit Dose Services (DUNS: 831995316)

Effective Date

March 1, 2022

Labeling Type

Human Prescription Drug Label

Active Ingredients

Sildenafil(20 mg in 1 1)

Manufacturing Establishments (1)

Unit Dose Services

Labeler

Unit Dose Services

DUNS Number

831995316

Products (1)

Sildenafil

NDC Product Code

50436-1210

Application Number

ANDA203814

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 6, 2019

Ingredients

SildenafilActive

Code: BW9B0ZE037Class: ACTIMQuantity: 20 mg in 1 1

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive

Code: O7TSZ97GEPClass: IACT

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