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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202090
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM OXYBATE SODIUM OXYBATE 0.5GM/ML SOLUTION;ORAL Discontinued None No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/17/2017 ORIG-1 Approval Not Applicable Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202090lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202090Orig1s000ltredt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/202090Orig1_Approval_Pkg.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/08/2025 SUPPL-10 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/202090Orig1s010ltr.pdf
12/08/2023 SUPPL-6 REMS - MODIFIED - D-N-A

Label is not available on this site.
01/03/2022 SUPPL-5 Labeling-Package Insert

Label is not available on this site.
01/03/2022 SUPPL-4 Labeling-Package Insert

Label is not available on this site.
01/03/2022 SUPPL-3 Labeling-Package Insert

Label is not available on this site.
01/03/2022 SUPPL-2 Labeling-Package Insert

Label is not available on this site.
01/03/2022 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
01/17/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202090lbl.pdf
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