Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Aphena Pharma Solutions - Tennessee, LLC
Aphena Pharma Solutions - Tennessee, LLC
128385585
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pentoxifylline
Product Details
NDC Product Code
43353-123Application Number
ANDA075028Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 15, 2016ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
PentoxifyllineActive
Code: SD6QCT3TSUClass: ACTIBQuantity: 400 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT