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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.

METOCURINE IODIDE

ANDA

Tentative Approval

METOCURINE IODIDE | A089443 | QUAD PHARMS

API Supply Chain0 active DMFs1 inactive

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

DIOSYNTH BVInactiveMETOCURINE IODIDE

DMF 42001981

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

Products (1)

#001 — 2MG/ML

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Injectable; Injection | Approved: N/A

No patent or exclusivity listings for this strength.