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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021333
Company: FERRING

Other Important Information from FDA

Products on NDA 021333

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021333

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

Labels for NDA 021333

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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