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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 009435
Company: FRESENIUS KABI USA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NESACAINE CHLOROPROCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription None Yes Yes
NESACAINE CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription AP Yes No
NESACAINE-MPF CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Discontinued None No No
NESACAINE-MPF CHLOROPROCAINE HYDROCHLORIDE 3% INJECTABLE;INJECTION Discontinued None No No
NESACAINE-MPF CHLOROPROCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription AP Yes Yes
NESACAINE-MPF CHLOROPROCAINE HYDROCHLORIDE 3% INJECTABLE;INJECTION Prescription AP Yes Yes

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
11/02/2018 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/009435s044lbl.pdf
02/19/2010 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009435s035s036lbl.pdf
02/19/2010 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009435s035s036lbl.pdf
06/21/2004 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/09435slr034_nesacaine_lbl.pdf
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