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POTASSIUM CITRATE

NDA

POTASSIUM CITRATE | N019647 | UT SOUTHWESTERN MEDCTR

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain2 active DMFs1 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

TAPI NL BVPOTASSIUM CITRATE USP

DMF 310682016

GLOBAL CALCIUM PRIVATE LTDPOTASSIUM CITRATE USP

DMF 368752022

ARCHER DANIELS MIDLAND COInactivePOTASSIUM CITRATE MONOHYDRATE

DMF 103011993

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (2)

Sort:

#001 — 20MEQ/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

FOR SOLUTION;ORAL | Approved: Oct 13, 1988

No patent or exclusivity listings for this strength.

#002 — 10MEQ/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

FOR SOLUTION;ORAL | Approved: Oct 13, 1988