Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 208055
Company: TORRENT
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 80MG TABLET;ORAL Discontinued None No No
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 120MG TABLET;ORAL Discontinued None No No
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE UNKNOWN UNKNOWN None (Tentative Approval) 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-2 Tentative Approval STANDARD

Label is not available on this site.

01/03/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208055Orig1s000TALtr.pdf

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