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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020630
Company: MYLAN INSTITUTIONAL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ULTIVA REMIFENTANIL HYDROCHLORIDE EQ 1MG BASE/VIAL INJECTABLE;INJECTION Prescription AP Yes No
ULTIVA REMIFENTANIL HYDROCHLORIDE EQ 2MG BASE/VIAL INJECTABLE;INJECTION Prescription AP Yes No
ULTIVA REMIFENTANIL HYDROCHLORIDE EQ 5MG BASE/VIAL INJECTABLE;INJECTION Prescription AP Yes Yes

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/15/2023 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020630s030lbl.pdf
10/07/2019 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020630s020lbl.pdf
06/21/2018 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020630s018lbl.pdf
06/21/2018 SUPPL-18 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020630s018lbl.pdf
12/16/2016 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020630s016lbl.pdf
12/16/2016 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020630s016lbl.pdf
03/08/2004 SUPPL-5 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20630se5-005_ultiva_lbl.pdf
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