desmopressin Nasal Spray

Brand(s)
DDAVP, Stimate
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Csl Behring Llc (2013-06-06)
Oldest Current Product
1978-02-21
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
NASAL SPRAY\DESMOPRESSIN
FDAOB
NASAL\SOLUTION\DESMOPRESSIN ACETATE
NASAL\SPRAY, METERED\DESMOPRESSIN ACETATE
SPL Active
NASAL\SOLUTION\DESMOPRESSIN ACETATE
NASAL\SPRAY, METERED\DESMOPRESSIN ACETATE
NASAL\SPRAY\DESMOPRESSIN ACETATE
SPL Moiety
NASAL\SOLUTION\DESMOPRESSIN
NASAL\SPRAY, METERED\DESMOPRESSIN
NASAL\SPRAY\DESMOPRESSIN

product(s) by strength(s)

desmopressin acetate 0.01 mg/actuat nasal spray

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000752452DDAVPNDASanofi-Aventis U.S. Llc1978-02-21DESMOPRESSIN ACETATENASALSOLUTIONNDA01792205e6330b-6569-436e-9caf-e86916460931

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1242080342ANDABausch & Lomb Incorporated1999-01-25DESMOPRESSIN ACETATENASALSOLUTIONANDA0748308ca799f1-7029-4527-9ab4-7512504bb8e2
2473350788ANDASun Pharma Global Fze2013-12-24DESMOPRESSIN ACETATENASALSOLUTIONANDA078271b47d691e-28a9-4e10-92b8-310aecc2f953
3605050815ANDAApotex Corp2005-01-27DESMOPRESSIN ACETATENASALSPRAYANDA0767031ac423b8-27a6-4cef-4a82-c50bf81b4f49
4627560161ANDASun Pharmaceutical Industries Limited2012-04-14DESMOPRESSIN ACETATENASALSOLUTIONANDA077212ceee4883-6c49-4538-a747-354d0743b221
5669930025NDA AUTHORIZED GENERICPrasco Laboratories2014-01-01DESMOPRESSIN ACETATENASALSPRAYNDA021333c9e4aedb-27d6-4499-9245-93937d3a375f

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685602ANDAPhysicians Total Care, Inc.2006-05-22DESMOPRESSIN ACETATENASALSOLUTION242080342ANDA074830b3b68b3a-aa82-4464-8146-51d27861023d

desmopressin acetate 0.15 mg/actuat nasal spray

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000536871StimateNDACsl Behring Llc2011-09-16DESMOPRESSIN ACETATENASALSPRAY, METEREDNDA02035530d4c387-b99c-49f8-a8bd-de23fdafb739

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA074830DESMOPRESSIN ACETATEBAUSCH AND LOMB PHARMACEUTICALS INC1999-01-25ANDA074830_001desmopressin Nasal Solution
2ANDA076703DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)APOTEX INC RICHMOND HILL2005-01-27ANDA076703_001desmopressin Nasal Solution
3ANDA077212DESMOPRESSIN ACETATESUN PHARMACEUTICAL INDUSTRIES LTD2012-04-12ANDA077212_001desmopressin Nasal Solution
4ANDA078271DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)SUN PHARMA GLOBAL FZE2013-12-23ANDA078271_001desmopressin Nasal Solution
5NDA017922DDAVPFERRING PHARMACEUTICALS INCNDA017922_001, NDA017922_002, NDA017922_003desmopressin Nasal Solution
6NDA019776CONCENTRAIDTrueFERRING PHARMACEUTICALS INC1990-12-26NDA019776_001desmopressin Nasal Solution
7NDA020355STIMATECSL BEHRING LLC1994-03-07NDA020355_001, NDA020355_002desmopressin Nasal Solution
8NDA021333MINIRINFERRING PHARMACEUTICALS INC2002-09-16NDA021333_001desmopressin Nasal Solution

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074830_001RXDESMOPRESSIN ACETATE (0.01MG/SPRAY)NASALSPRAY, METEREDTrueAB1999-01-25DESMOPRESSIN ACETATE
2ANDA076703_001RXDESMOPRESSIN ACETATE (0.01MG/SPRAY)NASALSPRAY, METEREDFalseAB2005-01-27DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)
3ANDA077212_001RXDESMOPRESSIN ACETATE (0.01%)NASALSOLUTIONFalseAB2012-04-12DESMOPRESSIN ACETATE
4ANDA078271_001RXDESMOPRESSIN ACETATE (0.01MG/SPRAY)NASALSPRAY, METEREDFalseAB2013-12-23DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)
5NDA017922_001RXDESMOPRESSIN ACETATE (0.01%)NASALSOLUTIONTrueABDDAVP
6NDA017922_002discontinuedDESMOPRESSIN ACETATE (0.01MG/SPRAY)NASALSPRAY, METEREDFalse1989-02-06DDAVP
7NDA017922_003RXDESMOPRESSIN ACETATE (0.01MG/SPRAY)NASALSPRAY, METEREDTrueAB1996-08-07DDAVP
8NDA019776_001discontinuedDESMOPRESSIN ACETATE (0.01%)NASALSOLUTIONFalse1990-12-26CONCENTRAID
9NDA020355_001discontinuedDESMOPRESSIN ACETATE (0.15MG/SPRAY)NASALSPRAY, METEREDFalse1994-03-07STIMATE
10NDA020355_002RXDESMOPRESSIN ACETATE (1.5MG/SPRAY)NASALSPRAY, METEREDTrue2007-10-24STIMATE
11NDA021333_001RXDESMOPRESSIN ACETATE (0.01MG/SPRAY)NASALSPRAY, METEREDTrueAB2002-09-16MINIRIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
105e6330b-6569-436e-9caf-e86916460931 (view SPL)DDAVP Nasal Spray(desmopressin acetate)prescriptionHuman PrescriptionSanofi-Aventis U.S. LlcMANUFACTURE2009-09-015000752452
21ac423b8-27a6-4cef-4a82-c50bf81b4f49 (view SPL)Desmopressin Nasal SpraySolution USP, 0.01%prescriptionHuman PrescriptionApotex Corp2012-03-072605050815
330d4c387-b99c-49f8-a8bd-de23fdafb739 (view SPL)Stimate (desmopressin acetate) Nasal Spray, 1.5 mg/mLprescriptionHuman PrescriptionCsl Behring LlcMANUFACTURE2013-06-066000536871
48ca799f1-7029-4527-9ab4-7512504bb8e2 (view SPL)Desmopressin Acetate Nasal Spray Solution, 10 mcg/0.1 mLprescriptionHuman PrescriptionBausch & Lomb IncorporatedMANUFACTURE2012-04-016242080342
5b3b68b3a-aa82-4464-8146-51d27861023d (view SPL)Desmopressin AcetateNasal Solution, 0.01%prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2011-02-181548685602
6b47d691e-28a9-4e10-92b8-310aecc2f953 (view SPL)Desmopressin Acetate Nasal Solution 0.01% (Nasal Spray)prescriptionHuman PrescriptionSun Pharma Global FzeANALYSIS, MANUFACTURE2015-05-072473350788
7c9e4aedb-27d6-4499-9245-93937d3a375f (view SPL)Desmopressin Acetate Nasal Spray, 10 mcg per 0.1 mLprescriptionHuman PrescriptionPrasco LaboratoriesMANUFACTURE2015-05-046669930025
8ceee4883-6c49-4538-a747-354d0743b221 (view SPL)Desmopressin Nasal Spray Solution, USP 0.01%prescriptionHuman PrescriptionSun Pharmaceutical Industries LimitedANALYSIS, MANUFACTURE2012-04-142627560161

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII