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FDA Approval Activities for this Drug…

Bupivacaine HCl Injection USP, 0.25%, 0.50% & 0.75%, International Medication Systems, Limited ANDA 76-012 Marcaine Spinal (bupivacaine hydrochloride in dextrose) injection, USP. Abbott NDA 18-692/S-007 BUPIVACAINE HYDROCHLORIDE Injection 0.25% MARCAINE HCL Abbott 018053 BUPIVACAINE HYDROCHLORIDE Injection 0.25% BUPIVACAINE HCL Abbott 016964 BUPIVACAINE HYDROCHLORIDE Injection 0.25% MARCAINE HCL PRESERVATIVE FREE Abbott 070583 BUPIVACAINE HYDROCHLORIDE Injection 0.25% BUPIVACAINE HCL Abbott 070586 BUPIVACAINE HYDROCHLORIDE Injection 0.25% BUPIVACAINE HCL Abbott 070590 BUPIVACAINE HYDROCHLORIDE Injection 0.25% BUPIVACAINE HCL Abbott 070597 BUPIVACAINE HYDROCHLORIDE Injection 0.5% BUPIVACAINE HCL Abbott 070609 BUPIVACAINE HYDROCHLORIDE Injection 0.5% BUPIVACAINE HCL Abbott 018053 BUPIVACAINE HYDROCHLORIDE Injection 0.5% BUPIVACAINE HCL Abbott 070584 BUPIVACAINE HYDROCHLORIDE Injection 0.5% BUPIVACAINE HCL Abbott 016964 BUPIVACAINE HYDROCHLORIDE Injection 0.5% MARCAINE HCL PRESERVATIVE FREE Abbott 016964 BUPIVACAINE HYDROCHLORIDE Injection 0.5% MARCAINE HCL Abbott 070587 BUPIVACAINE HYDROCHLORIDE Injection 0.75% BUPIVACAINE HCL Abbott 018053 BUPIVACAINE HYDROCHLORIDE Injection 0.75% BUPIVACAINE HCL Abbott 016964 BUPIVACAINE HYDROCHLORIDE Injection 0.75% MARCAINE HCL PRESERVATIVE FREE Abbott 070585 BUPIVACAINE HYDROCHLORIDE Injection 0.75% BUPIVACAINE HCL Abbott 018304 BUPIVACAINE HYDROCHLORIDE Injection 0.25% SENSORCAINE ASTRAZENECA 070552 BUPIVACAINE HYDROCHLORIDE Injection 0.25% SENSORCAINE ASTRAZENECA 070553 BUPIVACAINE HYDROCHLORIDE Injection 0.5% SENSORCAINE ASTRAZENECA 018304 BUPIVACAINE HYDROCHLORIDE Injection 0.5% SENSORCAINE ASTRAZENECA 018304 BUPIVACAINE HYDROCHLORIDE Injection 0.75% SENSORCAINE ASTRAZENECA 070554 BUPIVACAINE HYDROCHLORIDE Injection 0.75% SENSORCAINE ASTRAZENECA 076012 BUPIVACAINE HYDROCHLORIDE Injection 0.25% BUPIVACINE HCL PRESERVATIVE FREE INTL MEDICATED 076012 BUPIVACAINE HYDROCHLORIDE Injection 0.5% BUPIVACINE HCL PRESERVATIVE FREE INTL MEDICATED 076012 BUPIVACAINE HYDROCHLORIDE Injection 0.75% BUPIVACINE HCL PRESERVATIVE FREE INTL MEDICATED 071810 BUPIVACAINE HYDROCHLORIDE Spinal 0.75% BUPIVACAINE Abbott 018692 BUPIVACAINE HYDROCHLORIDE Spinal 0.75% MARCAINE Abbott 071202 BUPIVACAINE HYDROCHLORIDE Spinal 0.75% SENSORCAINE ASTRAZENECA 071165 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE Injection 0.25%;0.005MG/ML BUPIVACAINE HCL AND EPINEPHRINE Abbott 071166 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE Injection 0.25%;0.005MG/ML BUPIVACAINE HCL AND EPINEPHRINE Abbott 071167 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE Injection 0.25%;0.005MG/ML BUPIVACAINE HCL AND EPINEPHRINE Abbott 071168 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE Injection 0.5%;0.005MG/ML BUPIVACAINE HCL AND EPINEPHRINE Abbott 071169 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE Injection 0.5%;0.005MG/ML BUPIVACAINE HCL AND EPINEPHRINE Abbott 071170 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE Injection 0.5%;0.005MG/ML BUPIVACAINE HCL AND EPINEPHRINE Abbott 071171 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE Injection 0.75%;0.005MG/ML BUPIVACAINE HCL AND EPINEPHRINE Abbott 016964 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE Injection 0.25%;0.0091MG/ML MARCAINE HCL W/ EPINEPHRINE Abbott 016964 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE Injection 0.25%;0.0091MG/ML MARCAINE HCL W/ EPINEPHRINE PRESERVATIVE FREE Abbott 016964 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE Injection 0.5%;0.0091MG/ML MARCAINE HCL W/ EPINEPHRINE PRESERVATIVE FREE Abbott 016964 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE Injection 0.5%;0.0091MG/ML MARCAINE HCL W/ EPINEPHRINE Abbott 016964 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE Injection 0.75%;0.0091MG/ML MARCAINE HCL W/ EPINEPHRINE PRESERVATIVE FREE Abbott 070966 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE Injection 0.25%;0.0091MG/ML SENSORCAINE ASTRAZENECA | 070967 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE Injection 0.25%;0.0091MG/ML SENSORCAINE ASTRAZENECA | 070968 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE Injection 0.5%;0.0091MG/ML SENSORCAINE ASTRAZENECA | 018304 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE Injection 0.5%;0.0091MG/ML SENSORCAINE ASTRAZENECA | 018304 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE Injection 0.75%;0.0091MG/ML SENSORCAINE ASTRAZENECA | 021496 BUPIVACAINE HYDROCHLORIDE; LIDOCAINE HYDROCHLORIDE Injection 0.375% (37.5MG/10ML);EQ 1% (100MG/10ML) DUOCAINE AMPHASTAR | 020997 LEVOBUPIVACAINE HYDROCHLORIDE Injection 2.5MG BASE/ML CHIROCAINE PURDUE LP | 020997 LEVOBUPIVACAINE HYDROCHLORIDE Injection 5MG BASE/ML CHIROCAINE PURDUE LP | 020997 LEVOBUPIVACAINE HYDROCHLORIDE Injection 7.5MG BASE/ML CHIROCAINE PURDUE LP | Marcaine (Bupivacaine Hydrochloride) Injection and Marcaine w/Epinephrine, Hospira, Labeling Revision | Bupivacaine HCL Injection, Hospira, Labeling Supplement | Bupivacaine Hydrochloride & Epinephrine Injection, Septodont Inc., Approval

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