Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Direct_Rx
079254320
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Direct_Rx
Direct_Rx
Direct_Rx
079254320
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
72189-025Application Number
ANDA075191Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 2, 2019PentoxifyllineActive
Code: SD6QCT3TSUClass: ACTIBQuantity: 400 mg in 1 1
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT