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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208031
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 20MG TABLET;ORAL Discontinued None No No
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 40MG TABLET;ORAL Discontinued None No No
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 60MG TABLET;ORAL Discontinued None No No
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 80MG TABLET;ORAL Discontinued None No No
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 120MG TABLET;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
01/03/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208031Orig1s000TALtr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/06/2022 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

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