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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213330
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 10MG/2ML (5MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
LABETALOL HYDROCHLORIDE IN DEXTROSE LABETALOL HYDROCHLORIDE 200MG/200ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE LABETALOL HYDROCHLORIDE 100MG/100ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE LABETALOL HYDROCHLORIDE 200MG/200ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE LABETALOL HYDROCHLORIDE 300MG/300ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/09/2020 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213330s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213330Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213330Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/15/2023 SUPPL-5 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213330s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213330Orig1s005ltr.pdf
03/18/2022 SUPPL-3 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213330s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213330Orig1s003ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
06/15/2023 SUPPL-5 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213330s005lbl.pdf
06/15/2023 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213330s005lbl.pdf
03/18/2022 SUPPL-3 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213330s003lbl.pdf
11/09/2020 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213330s000lbl.pdf
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