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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204370
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VRAYLAR CARIPRAZINE HYDROCHLORIDE EQ 1.5MG BASE CAPSULE;ORAL Prescription AB Yes Yes
VRAYLAR CARIPRAZINE HYDROCHLORIDE EQ 3MG BASE CAPSULE;ORAL Prescription AB Yes No
VRAYLAR CARIPRAZINE HYDROCHLORIDE EQ 4.5MG BASE CAPSULE;ORAL Prescription AB Yes No
VRAYLAR CARIPRAZINE HYDROCHLORIDE EQ 6MG BASE CAPSULE;ORAL Prescription AB Yes 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
09/17/2015 ORIG-2 Approval Efficacy STANDARD

Label is not available on this site.

09/17/2015 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204370lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204370Orig1Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/204370Orig2s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/24/2019 SUPPL-6 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204370s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204370Orig1s006ltr.pdf
11/28/2018 SUPPL-5 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204370Orig1s005ltr.pdf
11/09/2017 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204370s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/0204370Orig1s002s003ltr.pdf
11/09/2017 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204370s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/0204370Orig1s002s003ltr.pdf
02/23/2017 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204370s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204370Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/24/2019 SUPPL-6 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204370s006lbl.pdf
11/09/2017 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204370s002s003lbl.pdf
11/09/2017 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204370s002s003lbl.pdf
02/23/2017 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204370s001lbl.pdf
09/17/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204370lbl.pdf

VRAYLAR

CAPSULE;ORAL; EQ 1.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARIPRAZINE HYDROCHLORIDE CARIPRAZINE HYDROCHLORIDE EQ 1.5MG BASE CAPSULE;ORAL Prescription No AB 213984 ZYDUS PHARMS
VRAYLAR CARIPRAZINE HYDROCHLORIDE EQ 1.5MG BASE CAPSULE;ORAL Prescription Yes AB 204370 ALLERGAN

CAPSULE;ORAL; EQ 3MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARIPRAZINE HYDROCHLORIDE CARIPRAZINE HYDROCHLORIDE EQ 3MG BASE CAPSULE;ORAL Prescription No AB 213984 ZYDUS PHARMS
VRAYLAR CARIPRAZINE HYDROCHLORIDE EQ 3MG BASE CAPSULE;ORAL Prescription Yes AB 204370 ALLERGAN

CAPSULE;ORAL; EQ 4.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARIPRAZINE HYDROCHLORIDE CARIPRAZINE HYDROCHLORIDE EQ 4.5MG BASE CAPSULE;ORAL Prescription No AB 213984 ZYDUS PHARMS
VRAYLAR CARIPRAZINE HYDROCHLORIDE EQ 4.5MG BASE CAPSULE;ORAL Prescription Yes AB 204370 ALLERGAN

CAPSULE;ORAL; EQ 6MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARIPRAZINE HYDROCHLORIDE CARIPRAZINE HYDROCHLORIDE EQ 6MG BASE CAPSULE;ORAL Prescription No AB 213984 ZYDUS PHARMS
VRAYLAR CARIPRAZINE HYDROCHLORIDE EQ 6MG BASE CAPSULE;ORAL Prescription Yes AB 204370 ALLERGAN
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