Orange Book product · Brand (NDA)
TRENTAL
PENTOXIFYLLINE
At a glance
Aug 30, 1984
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 30, 1984
42 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
PENTOXIFYLLINE
Strength
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 018631
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1999PENTOXIFYLLINEGeneric (ANDA)
ANDA 075199 · ANI PHARMS
- 1999PENTOXIFYLLINEGeneric (ANDA)
ANDA 075093 · IMPAX LABS
- 1999PENTOXIFYLLINEGeneric (ANDA)
ANDA 075191 · APOTEX
- 1999PENTOXIFYLLINEGeneric (ANDA)
ANDA 074874 · PLIVA
- 1999PENTOXILGeneric (ANDA)
ANDA 074962 · UPSHER SMITH LABS
- 1998PENTOXIFYLLINEGeneric (ANDA)
ANDA 075107 · ANI PHARMS
- 1998PENTOXIFYLLINEGeneric (ANDA)
ANDA 075028 · BAUSCH
- 1997PENTOXIFYLLINEGeneric (ANDA)
ANDA 074878 · ANI PHARMS
- 1997PENTOXIFYLLINEGeneric (ANDA)
ANDA 074877 · HERITAGE
- 1997PENTOXIFYLLINEGeneric (ANDA)
ANDA 074425 · RISING
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
