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POTASSIUM CITRATE

ANDA

POTASSIUM CITRATE | A214426 | HIBROW HEALTHCARE PRIVATE LTD

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: UROCIT-K(TE code: AB)

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 (3)

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#001 — 5MEQ

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Feb 19, 2021

No patent or exclusivity listings for this strength.

#002 — 10MEQ

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Feb 19, 2021

#003 — 15MEQ

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Feb 19, 2021