Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021333
Company: FERRING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MINIRIN DESMOPRESSIN ACETATE 0.01MG/SPRAY SPRAY, METERED;NASAL Discontinued None Yes 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
09/16/2002 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21333lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21-333ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021333s000_MinirinTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/29/2018 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021333s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/2018/021333Orig1s010ltr.pdf
09/04/2013 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/11/2013 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/08/2013 SUPPL-7 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021333s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021333Orig1s007ltr.pdf
09/04/2003 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21333slr001_Minirin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21333slr001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/29/2018 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021333s010lbl.pdf
11/08/2013 SUPPL-7 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021333s007lbl.pdf
11/08/2013 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021333s007lbl.pdf
09/04/2003 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21333slr001_Minirin_lbl.pdf
09/16/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21333lbl.pdf

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