Orange Book product · Brand (NDA)
UROCIT-K
POTASSIUM CITRATE
At a glance
Aug 30, 1985
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 30, 1985
41 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
POTASSIUM CITRATE
Strength
5MEQ
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
NDA 019071
Product number
001
Marketing status
RX
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.
- 1988POTASSIUM CITRATEBrand (NDA)
NDA 019647 · UT SW MEDCTR
- 2024POTASSIUM CITRATEGeneric (ANDA)
ANDA 213986 · TORRENT
- 2021POTASSIUM CITRATEGeneric (ANDA)
ANDA 214426 · HIBROW HLTHCARE
- 2021POTASSIUM CITRATEGeneric (ANDA)
ANDA 214420 · ASCENT PHARMS INC
- 2020POTASSIUM CITRATEGeneric (ANDA)
ANDA 212799 · BIONPHARMA
- 2020POTASSIUM CITRATEGeneric (ANDA)
ANDA 212779 · ANI PHARMS
- 2018POTASSIUM CITRATEGeneric (ANDA)
ANDA 209758 · TEVA PHARMS USA INC
- 2017POTASSIUM CITRATEGeneric (ANDA)
ANDA 206813 · STRIDES PHARMA
- 2014POTASSIUM CITRATEGeneric (ANDA)
ANDA 203546 · ZYDUS PHARMS
- 2006POTASSIUM CITRATEGeneric (ANDA)
ANDA 077440 · 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.
