Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019386
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BREVIBLOC ESMOLOL HYDROCHLORIDE 250MG/ML INJECTABLE; INJECTION Discontinued None No No
BREVIBLOC ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Discontinued None No No
BREVIBLOC ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Prescription AP Yes Yes
BREVIBLOC ESMOLOL HYDROCHLORIDE 20MG/ML INJECTABLE;INJECTION Discontinued None No No
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE;INJECTION Prescription None Yes Yes
BREVIBLOC IN PLASTIC CONTAINER ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE;INJECTION Prescription None Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/11/2012 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019386s043lbl.pdf
11/06/2007 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019386s039lbl.pdf

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