MedPath

Pentoxifylline

Pentoxifylline Extended-release Tablets, 400 mg.

Approved
Approval ID

73f8cef4-39f3-4f71-b3cc-8da07b8fd65f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 31, 2010

Manufacturers
FDA

State of Florida DOH Central Pharmacy

DUNS: 829348114

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 Code53808-0757
Application NumberANDA075199
Product Classification
M
Marketing Category
C73584
G
Generic Name
PENTOXIFYLLINE
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2010
FDA Product Classification

INGREDIENTS (5)

PENTOXIFYLLINEActive
Quantity: 400 mg in 1 1
Code: SD6QCT3TSU
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT

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Pentoxifylline - FDA Drug Approval Details