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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
STAT RX USA LLC
DUNS: 786036330
Effective Date
April 26, 2011
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.

STAT RX USA LLC

STAT RX USA LLC

786036330

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
16590-856
Application Number
ANDA075028
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 26, 2011
Code: SD6QCT3TSUClass: ACTIBQuantity: 400 mg in 1 1
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)Inactive
Code: S38J6RZN16Class: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
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