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FDA Approval

Sildenafil

CompanyNuCare Pharmaceuticals, Inc. (DUNS: 010632300)

Effective Date

May 4, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Sildenafil(20 mg in 1 1)

Manufacturing Establishments (1)

NuCare Pharmaceuticals, Inc.

Labeler

NuCare Pharmaceuticals, Inc.

DUNS Number

010632300

Products (1)

Sildenafil

NDC Product Code

70859-015

Application Number

ANDA203814

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 4, 2021

Ingredients

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SildenafilActive

Code: BW9B0ZE037Class: ACTIMQuantity: 20 mg in 1 1

CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive

Code: L11K75P92JClass: IACT

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