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Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.

PRALIDOXIME CHLORIDE

ANDA

Tentative Approval

PRALIDOXIME CHLORIDE | A072224 | QUAD PHARMS

API Supply Chain3 active DMFs1 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

CURIA NEW YORK INCPRALIDOXIME CHLORIDE USP

DMF 142081999

DISHMAN CARBOGEN AMCIS LTDPRALIDOXIME CHLORIDE

DMF 213072008

WAVELENGTH ENTERPRISES LTDPRALIDOXIME CHLORIDE

DMF 366162022

PHARM ECO LABORATORIES INCInactivePRALIDOXIME CHLORIDE USP

DMF 70651987

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

Products (1)

#001 — 1GM/VIAL

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Injectable; Injection | Approved: N/A

No patent or exclusivity listings for this strength.