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FDA ANDA · ANDA207948

LURASIDONE HYDROCHLORIDE

Sponsor: PAR PHARM INC

APPLICATION
ANDA207948
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

LURASIDONE HYDROCHLORIDENone (Tentative Approval)
LURASIDONE HYDROCHLORIDE 120MG · TABLET · ORAL
LURASIDONE HYDROCHLORIDENone (Tentative Approval)
LURASIDONE HYDROCHLORIDE 60MG · TABLET · ORAL
LURASIDONE HYDROCHLORIDENone (Tentative Approval)
LURASIDONE HYDROCHLORIDE 20MG · TABLET · ORAL
LURASIDONE HYDROCHLORIDENone (Tentative Approval)
LURASIDONE HYDROCHLORIDE 80MG · TABLET · ORAL
LURASIDONE HYDROCHLORIDENone (Tentative Approval)
LURASIDONE HYDROCHLORIDE 40MG · TABLET · ORAL

Approval history

2017-05-19UNKNOWN · Original · standard — Letter ↗TA
2017-05-19UNKNOWN · Supplement 1 · unknownTA
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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