Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020355
Company: FERRING PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
STIMATE DESMOPRESSIN ACETATE 0.15MG/SPRAY SPRAY, METERED;NASAL Discontinued None No No
STIMATE (NEEDS NO REFRIGERATION) DESMOPRESSIN ACETATE 0.15MG/SPRAY SPRAY, METERED;NASAL 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
03/07/1994 ORIG-1 Approval Type 3 - New Dosage Form STANDARD; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/10/2013 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020355s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020355Orig1s020ltr.pdf
12/18/2013 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

01/25/2013 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/24/2013 SUPPL-17 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020355s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020355Orig1s017ltr.pdf
09/16/2011 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020355s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020355s013ltr.pdf
10/24/2007 SUPPL-7 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020355s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020355s007ltr.pdf
08/21/2002 SUPPL-4 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20355slr004ltr.pdf
03/21/2000 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

03/29/1996 SUPPL-2 Labeling

Label is not available on this site.

10/02/1995 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/10/2013 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020355s020lbl.pdf
05/24/2013 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020355s017lbl.pdf
05/24/2013 SUPPL-17 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020355s017lbl.pdf
09/16/2011 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020355s013lbl.pdf
10/24/2007 SUPPL-7 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020355s007lbl.pdf
10/24/2007 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020355s007lbl.pdf

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