Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 208002
Company: AMNEAL PHARMS CO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 20MG TABLET;ORAL Prescription AB No No
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 40MG TABLET;ORAL Prescription AB No No
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 60MG TABLET;ORAL Prescription AB No No
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 80MG TABLET;ORAL Prescription AB No No
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 120MG TABLET;ORAL Prescription AB 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/2019/208002Orig1s000ltr.pdf

LURASIDONE HYDROCHLORIDE

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LATUDA LURASIDONE HYDROCHLORIDE 20MG TABLET;ORAL Prescription Yes AB 200603 SUNOVION PHARMS INC
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 208049 ACCORD HLTHCARE
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 208002 AMNEAL PHARMS CO
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 208028 INVAGEN PHARMS
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 208031 LUPIN LTD
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 208066 SUN PHARMA GLOBAL
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 208052 ZYDUS PHARMS USA INC

TABLET;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LATUDA LURASIDONE HYDROCHLORIDE 40MG TABLET;ORAL Prescription Yes AB 200603 SUNOVION PHARMS INC
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 40MG TABLET;ORAL Prescription No AB 208049 ACCORD HLTHCARE
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 40MG TABLET;ORAL Prescription No AB 208002 AMNEAL PHARMS CO
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 40MG TABLET;ORAL Prescription No AB 208028 INVAGEN PHARMS
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 40MG TABLET;ORAL Prescription No AB 208031 LUPIN LTD
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 40MG TABLET;ORAL Prescription No AB 208066 SUN PHARMA GLOBAL
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 40MG TABLET;ORAL Prescription No AB 208052 ZYDUS PHARMS USA INC

TABLET;ORAL; 60MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LATUDA LURASIDONE HYDROCHLORIDE 60MG TABLET;ORAL Prescription Yes AB 200603 SUNOVION PHARMS INC
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 208049 ACCORD HLTHCARE
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 208002 AMNEAL PHARMS CO
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 208028 INVAGEN PHARMS
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 208031 LUPIN LTD
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 208066 SUN PHARMA GLOBAL
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 208052 ZYDUS PHARMS USA INC

TABLET;ORAL; 80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LATUDA LURASIDONE HYDROCHLORIDE 80MG TABLET;ORAL Prescription Yes AB 200603 SUNOVION PHARMS INC
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB 208049 ACCORD HLTHCARE
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB 208002 AMNEAL PHARMS CO
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB 208028 INVAGEN PHARMS
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB 208031 LUPIN LTD
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB 208066 SUN PHARMA GLOBAL
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 80MG TABLET;ORAL Prescription No AB 208052 ZYDUS PHARMS USA INC

TABLET;ORAL; 120MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LATUDA LURASIDONE HYDROCHLORIDE 120MG TABLET;ORAL Prescription Yes AB 200603 SUNOVION PHARMS INC
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB 208049 ACCORD HLTHCARE
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB 208002 AMNEAL PHARMS CO
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB 208028 INVAGEN PHARMS
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB 208031 LUPIN LTD
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB 208066 SUN PHARMA GLOBAL
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB 208052 ZYDUS PHARMS USA INC

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