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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 219131
Company: ALMATICA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE EQ 80MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription None Yes Yes
DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE EQ 90MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription None Yes No
DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE EQ 120MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription None 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
02/27/2026 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219131Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/17/2026 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219131Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219131Orig1s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
08/17/2026 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219131Orig1s001lbl.pdf
08/17/2026 SUPPL-1 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219131Orig1s001lbl.pdf
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