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FDA Approval

SILDENAFIL CITRATE

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

NIVAGEN PHARMACEUTICALS, INC.

DUNS: 052032418

Effective Date

December 20, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Sildenafil(50 mg in 1 1)

Manufacturing Establishments1

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

UMEDICA LABORATORIES PRIVATE LIMITED

Labeler

NIVAGEN PHARMACEUTICALS, INC.

DUNS Number

920635096

Products3

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

SILDENAFIL CITRATE

Product Details

NDC Product Code

75834-240

Application Number

ANDA209302

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 20, 2023

Ingredients

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive

Code: L11K75P92JClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

SildenafilActive

Code: BW9B0ZE037Class: ACTIMQuantity: 50 mg in 1 1

SILDENAFIL CITRATE

Product Details

NDC Product Code

75834-241

Application Number

ANDA209302

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 20, 2023

Ingredients

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive

Code: L11K75P92JClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

SildenafilActive

Code: BW9B0ZE037Class: ACTIMQuantity: 100 mg in 1 1

SILDENAFIL CITRATE

Product Details

NDC Product Code

75834-272

Application Number

ANDA209302

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 20, 2023

Ingredients

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive

Code: L11K75P92JClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

SildenafilActive

Code: BW9B0ZE037Class: ACTIMQuantity: 25 mg in 1 1

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

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