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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.

RITODRINE HCL

ANDA

Tentative Approval

RITODRINE HYDROCHLORIDE | A070700 | 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.

LUSOCHIMICA SPAInactiveRITODRINE HYDROCHLORIDE

DMF 103151993

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

Products (1)

#001 — 10MG/ML

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Injectable; Injection | Approved: N/A

No patent or exclusivity listings for this strength.