Sildenafil

Basic Information

Product Name

Sildenafil

FDA Product Code

31722-136

Regulatory Information

NDC Product Code

31722-136

Application Number

ANDA213014

Marketing Category

C73584

Effective Date

March 13, 2024

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use SILDENAFIL FOR ORAL SUSPENSION safely and effectively. See full prescribing information for SILDENAFIL FOR ORAL SUSPENSION. SILDENAFIL for oral suspension Initial U.S. Approval: 1998

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

XANTHAN GUM

Code: TTV12P4NEE

Class Code: IACT

TRISODIUM CITRATE DIHYDRATE

Code: B22547B95K

Class Code: IACT

SORBITOL

Code: 506T60A25R

Class Code: IACT

SUCRALOSE

Code: 96K6UQ3ZD4

Class Code: IACT

SODIUM BENZOATE

Code: OJ245FE5EU

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

SILDENAFIL CITRATE

Quantity: 10 mg in 1 mL

Code: BW9B0ZE037

Class Code: ACTIM

Active Moieties

Code: 3M7OB98Y7H

Sildenafil

Basic Information

Regulatory Information

Company Information

Active Ingredients

ANHYDROUS CITRIC ACID

SILICON DIOXIDE

XANTHAN GUM

TRISODIUM CITRATE DIHYDRATE

SORBITOL

SUCRALOSE

SODIUM BENZOATE

TITANIUM DIOXIDE

Active Moieties

SILDENAFIL