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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022549
Company: NOVA PNEUMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADASUVE LOXAPINE 10MG POWDER;INHALATION Prescription None Yes Yes

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
01/27/2022 SUPPL-10 REMS - MODIFIED - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022549s010lbl.pdf
01/27/2022 SUPPL-10 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022549s010lbl.pdf
10/27/2021 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022549s009lbl.pdf
02/23/2017 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022549s006lbl.pdf
09/28/2016 SUPPL-5 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022549s005lbl.pdf
09/28/2016 SUPPL-5 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022549s005lbl.pdf
12/21/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022549s000lbl.pdf
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