Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075220
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE;INJECTION Discontinued None No 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
08/28/2000 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75220ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/29/2019 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

06/04/2008 SUPPL-18 Labeling

Label is not available on this site.

09/23/2007 SUPPL-17 Labeling

Label is not available on this site.

03/24/2008 SUPPL-14 Labeling

Label is not available on this site.

04/20/2005 SUPPL-8 Labeling

Label is not available on this site.

09/06/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

01/15/2002 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

01/15/2002 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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