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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020355
Company: FERRING PHARMS INC

Other Important Information from FDA

Products on NDA 020355

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	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020355

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.

Labels for NDA 020355

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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