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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209899
Company: CELGENE INTL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZEPOSIA OZANIMOD HYDROCHLORIDE EQ 0.23MG BASE CAPSULE;ORAL Prescription None Yes No
ZEPOSIA OZANIMOD HYDROCHLORIDE EQ 0.46MG BASE CAPSULE;ORAL Prescription None Yes No
ZEPOSIA OZANIMOD HYDROCHLORIDE EQ 0.92MG BASE CAPSULE;ORAL 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
03/25/2020 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209899s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209899Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/209899Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/29/2022 SUPPL-5 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209899Orig1s005ltr.pdf
12/15/2021 SUPPL-3 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209899s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209899Orig1s003ltr.pdf
05/27/2021 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209899s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209899Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/15/2021 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209899s003lbl.pdf
12/15/2021 SUPPL-3 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209899s003lbl.pdf
05/27/2021 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209899s001lbl.pdf
03/25/2020 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209899s000lbl.pdf
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