Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018938
Company: FERRING PHARMS INC

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
03/22/2018 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018938s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018938Orig1s035ltr.pdf
12/18/2015 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.
04/22/2015 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.
06/10/2014 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.
02/28/2014 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.
11/13/2013 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.
11/05/2015 SUPPL-29 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017922s042,018938s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017922Orig1s042,018938Orig1s029ltr.pdf
10/26/2007 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017922s038,018938s027,019955s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017922s038, 018938s027, 019955s013ltr.pdf
11/10/2005 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017922s034,018938s023,019955s010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017922s034,018938s023,019955s010ltr.pdf
11/12/2003 SUPPL-19 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17922slr031,18938slr019,19955slr005ltr.pdf
08/08/2002 SUPPL-17 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18938slr017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/018938_S017_DDAVP_AP.pdf
10/31/2000 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.
01/13/2000 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
09/24/1999 SUPPL-14 Manufacturing (CMC)-Control

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

Label is not available on this site.
04/25/1995 SUPPL-11 Manufacturing (CMC)-Control

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.
04/22/1992 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
01/03/1991 SUPPL-6 Manufacturing (CMC)-Control

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

Label is not available on this site.
07/01/1988 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.
05/25/1988 SUPPL-3 Manufacturing (CMC)

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
03/22/2018 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018938s035lbl.pdf
11/05/2015 SUPPL-29 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017922s042,018938s029lbl.pdf
11/05/2015 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017922s042,018938s029lbl.pdf
10/26/2007 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017922s038,018938s027,019955s013lbl.pdf
11/10/2005 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017922s034,018938s023,019955s010ltr.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 FERRING PHARMS INC
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE;INJECTION Prescription No AP 091374 LUITPOLD
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE;INJECTION Prescription No AP 204695 SAGENT PHARMS
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE;INJECTION Prescription No AP 204751 SAGENT PHARMS
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE;INJECTION Prescription No AP 091280 SUN PHARM INDS LTD
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE;INJECTION Prescription No AP 074888 TEVA PHARMS USA

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