PENTOXIFYLLINE
Pentoxifylline Extended-release Tablets, 400 mg.
Approved
Approval ID
24eb2c70-ca20-490c-837c-9de4f5914225
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 26, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
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 Code16590-856
Application NumberANDA075028
Product Classification
M
Marketing Category
C73584
G
Generic Name
PENTOXIFYLLINE
Product Specifications
Route of AdministrationORAL
Effective DateApril 26, 2011
FDA Product Classification
INGREDIENTS (6)
PENTOXIFYLLINEActive
Quantity: 400 mg in 1 1
Code: SD6QCT3TSU
Classification: ACTIB
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT