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FDA Approval

PENTOXIFYLLINE

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

FDA Approval Summary

Company
Effective Date
January 23, 2014
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Pentoxifylline(400 mg in 1 1)

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
33261-992
Application Number
ANDA075191
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 23, 2014
Code: SD6QCT3TSUClass: ACTIBQuantity: 400 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671PClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
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