Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 209087
Company: B BRAUN MEDICAL INC
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
04/02/2019 ORIG-1 Approval STANDARD

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 207266 BAXTER HLTHCARE CORP
BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE;SPINAL Prescription No AP 071810 HOSPIRA
MARCAINE BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE;SPINAL Prescription Yes AP 018692 HOSPIRA

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