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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019034
Company: FRESENIUS KABI USA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DILAUDID HYDROMORPHONE HYDROCHLORIDE 1MG/ML INJECTABLE;INJECTION Prescription AP Yes Yes
DILAUDID HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE;INJECTION Prescription AP Yes Yes
DILAUDID HYDROMORPHONE HYDROCHLORIDE 4MG/ML INJECTABLE;INJECTION Discontinued None Yes No
DILAUDID HYDROMORPHONE HYDROCHLORIDE 0.2MG/ML INJECTABLE;INJECTION Prescription AP Yes Yes
DILAUDID HYDROMORPHONE HYDROCHLORIDE 0.5MG/0.5ML INJECTABLE;INJECTION Prescription AP Yes Yes
DILAUDID-HP HYDROMORPHONE HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Discontinued None Yes No
DILAUDID-HP HYDROMORPHONE HYDROCHLORIDE 250MG/VIAL INJECTABLE;INJECTION Discontinued None No No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/15/2023 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019034s046lbl.pdf
01/16/2020 SUPPL-37 Manufacturing (CMC) Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019034s037lbl.pdf
10/07/2019 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019034s035lbl.pdf
02/10/2017 SUPPL-29 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019034s029lbl.pdf
12/16/2016 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019034s027lbl.pdf
12/16/2016 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019034s027lbl.pdf
06/30/2011 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019034s021lbl.pdf
04/30/2009 SUPPL-18 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019034s018lbl.pdf
06/12/2006 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019034s012lbl.pdf
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