FDA Orange Book · active-ingredient family
Potassium citrate
Potassium citrate is approved as 2 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:POTASSIUM CITRATE · NDA 019647
2
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · for solution, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| POTASSIUM CITRATERLD×2 | UT SW MEDCTR | NDA 019647 | — | Oct 13, 1988 | |
| UROCIT-KRLD×3 | MISSION PHARMA | NDA 019071 | AB | Aug 30, 1985 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| POTASSIUM CITRATE×3 | TORRENT | ANDA 213986 | — | Feb 06, 2024 | |
| POTASSIUM CITRATE×3 | HIBROW HLTHCARE | ANDA 214426 | AB | Feb 19, 2021 | |
| POTASSIUM CITRATE×3 | ASCENT PHARMS INC | ANDA 214420 | AB | Feb 05, 2021 | |
| POTASSIUM CITRATE×2 | BIONPHARMA | ANDA 212799 | AB | Jun 29, 2020 | |
| POTASSIUM CITRATE×2 | ANI PHARMS | ANDA 212779 | AB | Jan 14, 2020 | |
| POTASSIUM CITRATE×3 | TEVA PHARMS USA INC | ANDA 209758 | AB | Mar 05, 2018 | |
| POTASSIUM CITRATE×3 | STRIDES PHARMA | ANDA 206813 | AB | Sep 11, 2017 | |
| POTASSIUM CITRATE×3 | ZYDUS PHARMS | ANDA 203546 | AB | Aug 06, 2014 | |
| POTASSIUM CITRATE×2 | RISING | ANDA 077440 | AB | Jun 09, 2006 |
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.
Potassium citrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
