Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202102
Company: ALEMBIC PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARIPIPRAZOLE ARIPIPRAZOLE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription None No Yes
ARIPIPRAZOLE ARIPIPRAZOLE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription None 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
04/28/2015 ORIG-1 Approval Not Applicable Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202102s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202102Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/29/2017 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

03/29/2017 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

08/18/2016 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

03/29/2017 SUPPL-4 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

03/29/2017 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

03/29/2017 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Medication Guide

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/28/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202102s000lbl.pdf

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