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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215428
Company: ALMATICA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 30MG BASE CAPSULE;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
01/31/2022 ORIG-1 Approval Type 2 - New Active Ingredient and Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215428s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215428Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215428Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/18/2023 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215428s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215428Orig1s002,215133Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/18/2023 SUPPL-2 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215428s002lbl.pdf
08/18/2023 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215428s002lbl.pdf
01/31/2022 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215428s000lbl.pdf
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