FDA Orange Book · active-ingredient family
Pentoxifylline
Pentoxifylline is approved as 1 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TRENTAL · NDA 018631
1
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TRENTALRLD | VALIDUS PHARMS | NDA 018631 | — | Aug 30, 1984 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PENTOXIFYLLINE | ANI PHARMS | ANDA 075199 | — | Sep 03, 1999 | |
| PENTOXIFYLLINE | IMPAX LABS | ANDA 075093 | — | Aug 10, 1999 | |
| PENTOXIFYLLINE | APOTEX | ANDA 075191 | AB | Jun 09, 1999 | |
| PENTOXIFYLLINE | PLIVA | ANDA 074874 | — | May 25, 1999 | |
| PENTOXIL | UPSHER SMITH LABS | ANDA 074962 | — | Mar 31, 1999 | |
| PENTOXIFYLLINE | ANI PHARMS | ANDA 075107 | — | Sep 04, 1998 | |
| PENTOXIFYLLINE | BAUSCH | ANDA 075028 | — | Jul 20, 1998 | |
| PENTOXIFYLLINE | ANI PHARMS | ANDA 074878 | AB | Jul 09, 1997 | |
| PENTOXIFYLLINE | HERITAGE | ANDA 074877 | — | Jul 08, 1997 | |
| PENTOXIFYLLINE | RISING | ANDA 074425 | AB | Jul 08, 1997 |
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.
Pentoxifylline — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
