Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bausch Health Companies Inc.
Oceanside Pharmaceuticals
253292734
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
68682-101Application Number
ANDA075028Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 1, 2019ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
PentoxifyllineActive
Code: SD6QCT3TSUClass: ACTIBQuantity: 400 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT