Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207231
Company: INVENTIA HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ILOPERIDONE ILOPERIDONE 1MG TABLET;ORAL Prescription AB No No
ILOPERIDONE ILOPERIDONE 2MG TABLET;ORAL Prescription AB No No
ILOPERIDONE ILOPERIDONE 4MG TABLET;ORAL Prescription AB No No
ILOPERIDONE ILOPERIDONE 6MG TABLET;ORAL Prescription AB No No
ILOPERIDONE ILOPERIDONE 8MG TABLET;ORAL Prescription AB No No
ILOPERIDONE ILOPERIDONE 10MG TABLET;ORAL Prescription AB No No
ILOPERIDONE ILOPERIDONE 12MG 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
11/28/2016 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207231Orig1s000ltr.pdf

ILOPERIDONE

TABLET;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FANAPT ILOPERIDONE 1MG TABLET;ORAL Prescription Yes AB 022192 VANDA PHARMS INC
ILOPERIDONE ILOPERIDONE 1MG TABLET;ORAL Prescription No AB 207231 INVENTIA HLTHCARE

TABLET;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FANAPT ILOPERIDONE 2MG TABLET;ORAL Prescription Yes AB 022192 VANDA PHARMS INC
ILOPERIDONE ILOPERIDONE 2MG TABLET;ORAL Prescription No AB 207231 INVENTIA HLTHCARE

TABLET;ORAL; 4MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FANAPT ILOPERIDONE 4MG TABLET;ORAL Prescription Yes AB 022192 VANDA PHARMS INC
ILOPERIDONE ILOPERIDONE 4MG TABLET;ORAL Prescription No AB 207231 INVENTIA HLTHCARE

TABLET;ORAL; 6MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FANAPT ILOPERIDONE 6MG TABLET;ORAL Prescription Yes AB 022192 VANDA PHARMS INC
ILOPERIDONE ILOPERIDONE 6MG TABLET;ORAL Prescription No AB 207231 INVENTIA HLTHCARE

TABLET;ORAL; 8MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FANAPT ILOPERIDONE 8MG TABLET;ORAL Prescription Yes AB 022192 VANDA PHARMS INC
ILOPERIDONE ILOPERIDONE 8MG TABLET;ORAL Prescription No AB 207231 INVENTIA HLTHCARE

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FANAPT ILOPERIDONE 10MG TABLET;ORAL Prescription Yes AB 022192 VANDA PHARMS INC
ILOPERIDONE ILOPERIDONE 10MG TABLET;ORAL Prescription No AB 207231 INVENTIA HLTHCARE

TABLET;ORAL; 12MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FANAPT ILOPERIDONE 12MG TABLET;ORAL Prescription Yes AB 022192 VANDA PHARMS INC
ILOPERIDONE ILOPERIDONE 12MG TABLET;ORAL Prescription No AB 207231 INVENTIA HLTHCARE

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