Sildenafil

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Medsource Pharmaceuticals

DUNS Number

833685915

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

NDC Product Code

45865-833

Application Number

ANDA203814

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 24, 2018

Ingredients

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive

Code: O7TSZ97GEPClass: IACT

Code: BW9B0ZE037Class: ACTIMQuantity: 20 mg in 1 1