Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017922
Company: FERRING PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DDAVP DESMOPRESSIN ACETATE 0.01% SOLUTION;NASAL Prescription None Yes Yes
DDAVP DESMOPRESSIN ACETATE 0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SPRAY, METERED;NASAL Discontinued None Yes No
DDAVP (NEEDS NO REFRIGERATION) DESMOPRESSIN ACETATE 0.01MG/SPRAY SPRAY, METERED;NASAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/21/1978 ORIG-1 Approval Type 1 - New Molecular Entity 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
10/22/2018 SUPPL-46 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017922s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017922Orig1s046ltr.pdf
07/31/2015 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

02/28/2014 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

11/05/2015 SUPPL-42 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient 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-39 Labeling

Label is not available on this site.

10/26/2007 SUPPL-38 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-34 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-31 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17922slr031,18938slr019,19955slr005ltr.pdf
02/28/2001 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

10/31/2000 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

07/05/2000 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

09/24/1999 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

04/13/1998 SUPPL-25 Labeling

Label is not available on this site.

01/16/1996 SUPPL-24 Labeling

Label is not available on this site.

08/07/1996 SUPPL-23 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/26/1995 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

09/27/1991 SUPPL-21 Labeling

Label is not available on this site.

04/22/1992 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

08/23/1990 SUPPL-19 Labeling

Label is not available on this site.

07/19/1989 SUPPL-18 Labeling

Label is not available on this site.

06/23/1989 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/25/1988 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/29/1988 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

02/06/1989 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/28/1989 SUPPL-12 Efficacy-New Indication

Label is not available on this site.

11/07/1985 SUPPL-11 Labeling

Label is not available on this site.

11/27/1984 SUPPL-10 Labeling

Label is not available on this site.

06/01/1984 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/21/1983 SUPPL-7 Labeling

Label is not available on this site.

03/24/1983 SUPPL-6 Labeling

Label is not available on this site.

08/27/1982 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

06/08/1982 SUPPL-4 Labeling

Label is not available on this site.

05/21/1981 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/28/1980 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/22/2018 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017922s046lbl.pdf
11/05/2015 SUPPL-42 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017922s042,018938s029lbl.pdf
11/05/2015 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017922s042,018938s029lbl.pdf
11/05/2015 SUPPL-42 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017922s042,018938s029lbl.pdf
10/26/2007 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017922s038,018938s027,019955s013lbl.pdf
11/10/2005 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017922s034,018938s023,019955s010ltr.pdf

DDAVP

There are no Therapeutic Equivalents.

DDAVP (NEEDS NO REFRIGERATION)

SPRAY, METERED;NASAL; 0.01MG/SPRAY
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DDAVP (NEEDS NO REFRIGERATION) DESMOPRESSIN ACETATE 0.01MG/SPRAY SPRAY, METERED;NASAL Prescription Yes AB 017922 FERRING PHARMS INC
DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE 0.01MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 074830 BAUSCH AND LOMB
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) DESMOPRESSIN ACETATE 0.01MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 076703 APOTEX INC
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) DESMOPRESSIN ACETATE 0.01MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 078271 SUN PHARM
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) DESMOPRESSIN ACETATE 0.01MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 091345 ZYDUS PHARMS
MINIRIN DESMOPRESSIN ACETATE 0.01MG/SPRAY SPRAY, METERED;NASAL Prescription Yes AB 021333 FERRING

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