PENTOXIFYLLINE
PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400 mg
Approved
Approval ID
73a76a95-ada5-4707-ab89-fd60e8eda64e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 25, 2014
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PENTOXIFYLLINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67544-252
Application NumberANDA075191
Product Classification
M
Marketing Category
C73584
G
Generic Name
PENTOXIFYLLINE
Product Specifications
Route of AdministrationORAL
Effective DateJune 25, 2014
FDA Product Classification
INGREDIENTS (7)
PENTOXIFYLLINEActive
Quantity: 400 mg in 1 1
Code: SD6QCT3TSU
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT