Original New Drug Application Approvals by US FDA (01-15 October 2021)

15 Oct 2021
Original New Drug Application Approvals by US FDA (01-15 October 2021)
New drug applications approved by US FDA as of 01-15 October 2021 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

SERTRALINE HYDROCHLORIDE
  • Active Ingredient(s): Sertraline Hydrochlorid
  • Strength: 150MG; 200MG
  • Dosage Form(s) / Route(s): Capsule; Coral
  • Company: Almatica
  • Approval Date: 04 October 2021
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of (1):
    • Major depressive disorder (MDD) in adults
    • Obsessive-compulsive disorder (OCD) in adults and pediatric patients 6 years and older
  • Approved Label: 04  October 2021 (PDF)
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