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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018938
Company: NORDIC PHARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DDAVP DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE;INJECTION Prescription AP Yes Yes
DDAVP DESMOPRESSIN ACETATE 0.015MG/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
03/30/1984 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/21/2022 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018938Orig1s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/018938Orig1s039ltr.pdf
03/22/2018 SUPPL-35 Labeling-Package Insert

Label is not available on this site.
11/05/2015 SUPPL-29 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.
10/26/2007 SUPPL-27 Labeling

Label is not available on this site.
11/10/2005 SUPPL-23 Labeling

Label is not available on this site.
11/12/2003 SUPPL-19 Labeling

Label is not available on this site.
08/08/2002 SUPPL-17 Labeling

Label is not available on this site.
08/17/1998 SUPPL-13 Labeling

Label is not available on this site.
03/13/1995 SUPPL-10 Labeling

Label is not available on this site.
01/11/1994 SUPPL-9 Labeling

Label is not available on this site.
05/12/1993 SUPPL-8 Labeling

Label is not available on this site.
04/03/1990 SUPPL-5 Labeling

Label is not available on this site.
11/07/1985 SUPPL-2 Labeling

Label is not available on this site.
12/20/1984 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
07/21/2022 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018938Orig1s039lbl.pdf

DDAVP

INJECTABLE;INJECTION; 0.004MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DDAVP DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE;INJECTION Prescription Yes AP 018938 NORDIC PHARMA
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE;INJECTION Prescription No AP 215961 DR REDDYS
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE;INJECTION Prescription No AP 216904 GLAND
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE;INJECTION Prescription No AP 216922 GLAND
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE;INJECTION Prescription No AP 074888 MEITHEAL
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE;INJECTION Prescription No AP 204695 SAGENT PHARMS INC
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE;INJECTION Prescription No AP 204751 SAGENT PHARMS INC
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE;INJECTION Prescription No AP 210218 UBI
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE;INJECTION Prescription No AP 210223 UBI
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