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BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE

ANDA

BUPIVACAINE HYDROCHLORIDE | A204842 | HIKMA PHARMACEUTICALS

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: MARCAINE HYDROCHLORIDE(TE code: AP)

API Supply Chain6 active DMFs1 inactive

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

CAMBREX KARLSKOGA ABBUPIVACAINE HYDROCHLORIDE

DMF 59841985

SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRLBUPIVACAINE HYDROCHLORIDE

DMF 64951986

DISHMAN CARBOGEN AMCIS LTDBUPIVACAINE HYDROCHLORIDE

DMF 209592007

EXCELLA GMBH AND CO KGBUPIVACAINE HYDROCHLORIDE

DMF 211962007

MOEHS IBERICA SLBUPIVACAINE HYDROCHLORIDE

DMF 222282008

APEX HEALTHCARE LTDBUPIVACAINE HYDROCHLORIDE USP

DMF 423242025

FRESENIUS KABI ONCOLOGY LTDInactiveBUPIVACAINE HYDROCHLORIDE

DMF 266492012

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

Products (3)

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#001 — 0.25%

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Feb 11, 2021

No patent or exclusivity listings for this strength.

#002 — 0.5%

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Feb 11, 2021

#003 — 0.75%

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Feb 11, 2021