Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020120
Company: LUPIN ATLANTIS
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 |