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SENSORCAINE

ANDA

BUPIVACAINE HYDROCHLORIDE | A070552 | FRESENIUS KABI USA LLC

1 strength0 unique patents0 unique exclusivities

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

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Abbott Laboratories FDA-1988-P-0375 Abbott Laboratories submitted a petition on June 7, 1988, requesting ANDA status for 0.125% Bupivacaine Hydrochloride Injection, USP in 100 mL PVC flexible containers containing 125 mg total drug per container. The proposed product is identical in formulation, usage, and total drug amount to current	Other	2017-06-28	Withdrawn	Abbott Laboratories

Source: Regulations.gov. FDA citizen petitions matched by application number.

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 (1)

#001 — 0.25%

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: May 21, 1986

No patent or exclusivity listings for this strength.