Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020120
Company: LUPIN ATLANTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALLERNAZE TRIAMCINOLONE ACETONIDE 0.05MG/SPRAY SPRAY, METERED;NASAL Discontinued 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
02/04/2000 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20120lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20120ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-120_Tri-Nasal.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/07/2009 SUPPL-2 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020120s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020120s002ltr.pdf
03/27/2001 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/07/2009 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020120s002lbl.pdf
01/07/2009 SUPPL-2 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020120s002lbl.pdf
02/04/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20120lbl.pdf

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