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FDA Approval

PENTOXIFYLLINE

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

FDA Approval Summary

Effective Date
June 25, 2014
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Pentoxifylline(400 mg in 1 1)

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
67544-252
Application Number
ANDA075191
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 25, 2014
Code: SD6QCT3TSUClass: ACTIBQuantity: 400 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
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