desmopressin Nasal Solution

Brand(s)
DDAVP
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Ferring Pharmaceuticals Inc. (2012-03-31)
Oldest Current Product
1999-08-10
License(s)
NDA
RxNORM
NASAL SOLUTION\DESMOPRESSIN
FDAOB
NASAL\SOLUTION\DESMOPRESSIN ACETATE
NASAL\SPRAY, METERED\DESMOPRESSIN ACETATE
SPL Active
NASAL\SOLUTION\DESMOPRESSIN ACETATE
SPL Moiety
NASAL\SOLUTION\DESMOPRESSIN

product(s) by strength(s)

desmopressin acetate 0.1 mg/ml nasal solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1555665020NDAFerring Pharmaceuticals Inc.1999-08-10DESMOPRESSIN ACETATENASALSOLUTIONNDA0179223f0f29b0-1ffb-4b14-9eb0-e620151c565c

application(s)

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

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)
13f0f29b0-1ffb-4b14-9eb0-e620151c565c (view SPL)DESMOPRESSIN ACETATERhinal Tube Rx onlyprescriptionHuman PrescriptionFerring Pharmaceuticals Inc.manufacture, pack2012-03-3122555665020
295e53e87-2d52-4e37-93ea-89f440938f7a (view SPL)DDAVP Rhinal Tube(desmopressin acetate)prescriptionHuman PrescriptionSanofi-Aventis U.S. LlcANALYSIS, LABEL, MANUFACTURE, PACK2012-07-197000752450

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