FDA Orange Book · active-ingredient family
Pindolol
Pindolol is approved as 1 brand and 14 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:VISKEN · NDA 018285
1
Brand (NDA)
14
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VISKENRLD×2 | NOVARTIS | NDA 018285 | — | Sep 03, 1982 |
Generic (ANDA) products (14)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PINDOLOL×2 | UNICHEM | ANDA 211712 | AB | Aug 01, 2019 | |
| PINDOLOL×2 | ZYDUS PHARMS | ANDA 209866 | — | Aug 18, 2017 | |
| PINDOLOL×2 | MPP PHARMA | ANDA 205415 | AB | Jan 13, 2016 | |
| PINDOLOL×2 | COSETTE | ANDA 074123 | — | Apr 17, 1997 | |
| PINDOLOL×2 | NOSTRUM LABS | ANDA 074474 | — | Oct 28, 1996 | |
| PINDOLOL×2 | WATSON LABS | ANDA 074437 | — | Feb 27, 1995 | |
| PINDOLOL×2 | SUN PHARM INDUSTRIES | ANDA 074063 | AB | Jan 27, 1994 | |
| PINDOLOL×2 | COSETTE | ANDA 073661 | — | Oct 31, 1993 | |
| PINDOLOL×2 | PUREPAC PHARM | ANDA 074125 | — | Apr 28, 1993 | |
| PINDOLOL×2 | ANI PHARMS | ANDA 073609 | AB | Mar 29, 1993 | |
| PINDOLOL×2 | COSETTE | ANDA 073687 | — | Feb 26, 1993 | |
| PINDOLOL | MYLAN PHARMS INC | ANDA 074013 | — | Sep 24, 1992 | |
| PINDOLOL | MYLAN PHARMS INC | ANDA 074018 | — | Sep 24, 1992 | |
| PINDOLOL×2 | AUROBINDO PHARMA USA | ANDA 074019 | AB | Sep 03, 1992 |
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.
Pindolol — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
