MedPath
FDA Approval

SILDENAFIL

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

FDA Approval Summary

Company
Effective Date
November 6, 2014
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Sildenafil(20 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Northwind Pharmaceuticals, LLC

036986393

Manufacturing Establishments1

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

Northwind Pharmaceuticals, LLC

Northwind Pharmaceuticals, LLC

Northwind Pharmaceuticals, LLC

036986393

Products1

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

SILDENAFIL

Product Details

NDC Product Code
51655-131
Application Number
ANDA091479
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
November 6, 2014
Code: BW9B0ZE037Class: ACTIMQuantity: 20 mg in 1 1
© Copyright 2025. All Rights Reserved by MedPath