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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.

ERYTHROMYCIN LACTOBIONATE

ANDA

Tentative Approval

ERYTHROMYCIN LACTOBIONATE | A062660 | QUAD PHARMS

API Supply Chain3 active DMFs

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

APITORIA PHARMA PRIVATE LTDERYTHROMYCIN LACTOBIONATE

DMF 340722019

GLAND PHARMA LTDERYTHROMYCIN LACTOBIONATE

DMF 344262019

BIOPHORE INDIA PHARMACEUTICALS PVT LTDERYTHROMYCIN LACTOBIONATE

DMF 347502020

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

Products (2)

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#001 — EQ 500MG BASE/VIAL

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Injectable; Injection | Approved: N/A

No patent or exclusivity listings for this strength.

#003 — EQ 1GM BASE/VIAL

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Injectable; Injection | Approved: N/A