Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074830
Company: BAUSCH

Products on ANDA 074830

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.01MG/SPRAY	SPRAY, METERED;NASAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074830

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/25/1999	ORIG-1	Approval			Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74830ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-830_Desmopressin.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2021	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
08/18/2021	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
01/14/2015	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
04/02/2015	SUPPL-15	Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
04/25/2008	SUPPL-13	Labeling		Label is not available on this site.
09/21/2004	SUPPL-8	Labeling		Label is not available on this site.
10/25/1999	SUPPL-4	Labeling		Label is not available on this site.
04/28/2000	SUPPL-2	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
09/13/1999	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.