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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071810
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE;SPINAL Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/11/1987 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/09/2020 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

08/25/2015 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

04/07/2010 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

07/15/1997 SUPPL-8 Labeling

Label is not available on this site.

08/08/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/02/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/23/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/20/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

BUPIVACAINE HYDROCHLORIDE

INJECTABLE;SPINAL; 0.75%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE;SPINAL Prescription No AP 209087 B BRAUN MEDICAL INC
BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE;SPINAL Prescription No AP 071810 HOSPIRA
BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE;SPINAL Prescription No AP 212822 HUONS
MARCAINE BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE;SPINAL Prescription Yes AP 018692 HOSPIRA
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