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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204168
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FETZIMA LEVOMILNACIPRAN HYDROCHLORIDE EQ 20MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
FETZIMA LEVOMILNACIPRAN HYDROCHLORIDE EQ 40MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
FETZIMA LEVOMILNACIPRAN HYDROCHLORIDE EQ 80MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
FETZIMA LEVOMILNACIPRAN HYDROCHLORIDE EQ 120MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/25/2013 ORIG-1 Approval Type 2 - New Active Ingredient STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204168s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204168Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204168Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204168Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/20/2021 SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204168s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020822Orig1s052, 021365Orig1s038, 021323Orig1s053, 022567Orig1s022, 204168Orig1s007ltr.pdf
10/07/2019 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204168s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204168Orig1s006ltr.pdf
12/19/2017 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204168s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204168Orig1s005ltr.pdf
01/04/2017 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204168s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204168Orig1s004ltr.pdf
06/05/2015 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/18/2014 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204168s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204168Orig1s002ltr.pdf
05/23/2014 SUPPL-1 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204168Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204168Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/20/2021 SUPPL-7 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204168s007lbl.pdf
09/20/2021 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204168s007lbl.pdf
10/07/2019 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204168s006lbl.pdf
12/19/2017 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204168s005lbl.pdf
01/04/2017 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204168s004lbl.pdf
07/18/2014 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204168s002lbl.pdf
05/23/2014 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204168Orig1s001lbl.pdf
07/25/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204168s000lbl.pdf
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