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
51655-172Application Number
ANDA202025Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
April 24, 2023CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CALCIUM PHOSPHATE, MONOBASIC, ANHYDROUSInactive
Code: 701EKV9RMNClass: IACT
SildenafilActive
Code: BW9B0ZE037Class: ACTIMQuantity: 20 mg in 1 1