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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
May 31, 2010
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.

State of Florida DOH Central Pharmacy

State of Florida DOH Central Pharmacy

829348114

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
53808-0758
Application Number
ANDA074425
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 31, 2010
Code: SD6QCT3TSUClass: ACTIBQuantity: 400 mg in 1 1
D&C RED NO. 30Inactive
Code: 2S42T2808BClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)Inactive
Code: 8136Y38GY5Class: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WOClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1AClass: IACT
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