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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
Proficient Rx LP
DUNS: 079196022
Effective Date
July 6, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Sildenafil(100 mg in 1 1)

Manufacturing Establishments1

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

Proficient Rx LP

Proficient Rx LP

079196022

Products1

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
71205-657
Application Number
ANDA209302
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
July 6, 2023
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
Code: BW9B0ZE037Class: ACTIMQuantity: 100 mg in 1 1
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