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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209830
Company: ALKERMES INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARISTADA INITIO KIT ARIPIPRAZOLE LAUROXIL 675MG/2.4ML (281.25MG/ML) SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 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
06/29/2018 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209830lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209830Orig1s000TOC.html
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/22/2025 SUPPL-20 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209830s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/207533Orig1s031,209830Orig1s020ltr.pdf
03/30/2021 SUPPL-9 Labeling-Package Insert, Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207533Orig1s021,209830Orig1s009ltr.pdf
08/27/2020 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207533s017,209830s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207533Orig1s017,%20209830Orig1s005ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
01/22/2025 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209830s020lbl.pdf
01/22/2025 SUPPL-20 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209830s020lbl.pdf
08/27/2020 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207533s017,209830s005lbl.pdf
06/29/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209830lbl.pdf
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