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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203802
Company: RK PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PALIPERIDONE PALIPERIDONE 1.5MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
PALIPERIDONE PALIPERIDONE 3MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
PALIPERIDONE PALIPERIDONE 6MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
PALIPERIDONE PALIPERIDONE 9MG TABLET, EXTENDED RELEASE;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
09/24/2015 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/29/2020 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

05/29/2020 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

05/29/2020 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

05/29/2020 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

05/29/2020 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

PALIPERIDONE

TABLET, EXTENDED RELEASE;ORAL; 1.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INVEGA PALIPERIDONE 1.5MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021999 JANSSEN PHARMS
PALIPERIDONE PALIPERIDONE 1.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202645 ACTAVIS LABS FL INC
PALIPERIDONE PALIPERIDONE 1.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204707 AMNEAL PHARMS
PALIPERIDONE PALIPERIDONE 1.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 212807 CSPC OUYI
PALIPERIDONE PALIPERIDONE 1.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204452 INVENTIA
PALIPERIDONE PALIPERIDONE 1.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 208643 LUPIN LTD
PALIPERIDONE PALIPERIDONE 1.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203802 RK PHARMA
PALIPERIDONE PALIPERIDONE 1.5mg TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205618 SUN PHARM

TABLET, EXTENDED RELEASE;ORAL; 3MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INVEGA PALIPERIDONE 3MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021999 JANSSEN PHARMS
PALIPERIDONE PALIPERIDONE 3MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202645 ACTAVIS LABS FL INC
PALIPERIDONE PALIPERIDONE 3MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204707 AMNEAL PHARMS
PALIPERIDONE PALIPERIDONE 3MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 212807 CSPC OUYI
PALIPERIDONE PALIPERIDONE 3MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204452 INVENTIA
PALIPERIDONE PALIPERIDONE 3MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 208643 LUPIN LTD
PALIPERIDONE PALIPERIDONE 3MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203802 RK PHARMA
PALIPERIDONE PALIPERIDONE 3MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205618 SUN PHARM

TABLET, EXTENDED RELEASE;ORAL; 6MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INVEGA PALIPERIDONE 6MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021999 JANSSEN PHARMS
PALIPERIDONE PALIPERIDONE 6MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202645 ACTAVIS LABS FL INC
PALIPERIDONE PALIPERIDONE 6MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204707 AMNEAL PHARMS
PALIPERIDONE PALIPERIDONE 6MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 212807 CSPC OUYI
PALIPERIDONE PALIPERIDONE 6MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204452 INVENTIA
PALIPERIDONE PALIPERIDONE 6MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 208643 LUPIN LTD
PALIPERIDONE PALIPERIDONE 6MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203802 RK PHARMA
PALIPERIDONE PALIPERIDONE 6MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205618 SUN PHARM

TABLET, EXTENDED RELEASE;ORAL; 9MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INVEGA PALIPERIDONE 9MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021999 JANSSEN PHARMS
PALIPERIDONE PALIPERIDONE 9MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202645 ACTAVIS LABS FL INC
PALIPERIDONE PALIPERIDONE 9MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204707 AMNEAL PHARMS
PALIPERIDONE PALIPERIDONE 9MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 212807 CSPC OUYI
PALIPERIDONE PALIPERIDONE 9MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204452 INVENTIA
PALIPERIDONE PALIPERIDONE 9MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 208643 LUPIN LTD
PALIPERIDONE PALIPERIDONE 9MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203802 RK PHARMA
PALIPERIDONE PALIPERIDONE 9MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205618 SUN PHARM
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