desmopressin Injectable Solution

Brand(s)
DDAVP
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Ferring Pharmaceuticals Inc. (2014-12-22)
Oldest Current Product
1984-03-30
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\DESMOPRESSIN
FDAOB
INJECTION\INJECTION\DESMOPRESSIN ACETATE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\DESMOPRESSIN ACETATE
INTRAVENOUS\INJECTION\DESMOPRESSIN ACETATE
INTRAVENOUS\SOLUTION\DESMOPRESSIN ACETATE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\DESMOPRESSIN
INTRAVENOUS\INJECTION\DESMOPRESSIN
INTRAVENOUS\SOLUTION\DESMOPRESSIN

product(s) by strength(s)

desmopressin acetate 0.004 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1555662200DDAVPNDAFerring Pharmaceuticals Inc.1984-03-30DESMOPRESSIN ACETATEINTRAVENOUSINJECTIONNDA018938651f6fee-a2c7-431b-8d5d-58b156c72244
2555662300DDAVPNDAFerring Pharmaceuticals Inc.1984-03-30DESMOPRESSIN ACETATEINTRAVENOUSINJECTIONNDA018938651f6fee-a2c7-431b-8d5d-58b156c72244
3699180901NDAAmring Pharmaceuticals Inc.1999-10-26DESMOPRESSIN ACETATEINTRAVENOUSSOLUTIONNDA01893829df0492-f7ef-47bb-aa67-4ef9e5c2846f

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004092265ANDAHospira, Inc.2000-08-28, 2015-01-01DESMOPRESSIN ACETATEINTRAVENOUSINJECTION, SOLUTIONANDA0752205fe83452-1670-487d-feb4-27d4bd75a147, c7c7ee28-c820-44a2-a441-234c2e43cd18
2007035051ANDATeva Parenteral Medicines, Inc1997-11-01DESMOPRESSIN ACETATEINTRAVENOUSINJECTIONANDA074888870d88c3-4388-454b-9360-22c582d6bfe1
3007035054ANDATeva Parenteral Medicines, Inc1997-11-01DESMOPRESSIN ACETATEINTRAVENOUSINJECTIONANDA074888870d88c3-4388-454b-9360-22c582d6bfe1
4627560529ANDASun Pharmaceutical Industries Limited2013-01-30, 2014-02-20DESMOPRESSIN ACETATEINTRAVENOUSINJECTION, SOLUTIONANDA0912802dc2cec8-6953-4a33-9356-11534fba1fb8, 9fd48eec-aa24-4888-b99f-d409ada958a7

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1555665030NDAFerring Pharmaceuticals Inc.1999-10-26DESMOPRESSIN ACETATEINTRAVENOUSSOLUTION00075245101NDA018938fd7672cb-4c15-403c-8e04-68369ad9bb77
2555665040NDAFerring Pharmaceuticals Inc.1999-10-26DESMOPRESSIN ACETATEINTRAVENOUSSOLUTION00075245153NDA018938fd7672cb-4c15-403c-8e04-68369ad9bb77

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074574DESMOPRESSIN ACETATE PRESERVATIVE FREETrueBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC2000-02-18ANDA074574_001
2ANDA074575DESMOPRESSIN ACETATETrueBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC2000-02-18ANDA074575_001
3ANDA074888DESMOPRESSIN ACETATETEVA PHARMACEUTICALS USA1997-10-15ANDA074888_001
4ANDA075220DESMOPRESSIN ACETATEHOSPIRA INC2000-08-28ANDA075220_001
5ANDA091280DESMOPRESSIN ACETATESUN PHARMACEUTICAL INDUSTRIES LTD2013-01-25ANDA091280_001
6NDA018938DDAVPFERRING PHARMACEUTICALS INC1984-03-30NDA018938_001, NDA018938_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA074574_001discontinuedDESMOPRESSIN ACETATE (0.004MG/ML)INJECTIONFalse2000-02-18DESMOPRESSIN ACETATE PRESERVATIVE FREE
2ANDA074575_001discontinuedDESMOPRESSIN ACETATE (0.004MG/ML)INJECTIONFalse2000-02-18DESMOPRESSIN ACETATE
3ANDA074888_001RXDESMOPRESSIN ACETATE (0.004MG/ML)INJECTIONFalseAP1997-10-15DESMOPRESSIN ACETATE
4ANDA075220_001RXDESMOPRESSIN ACETATE (0.004MG/ML)INJECTIONFalseAP2000-08-28DESMOPRESSIN ACETATE
5ANDA091280_001RXDESMOPRESSIN ACETATE (0.004MG/ML)INJECTIONFalseAP2013-01-25DESMOPRESSIN ACETATE
6NDA018938_001RXDESMOPRESSIN ACETATE (0.004MG/ML)INJECTIONTrueAP1984-03-30DDAVP
7NDA018938_002discontinuedDESMOPRESSIN ACETATE (0.015MG/ML)INJECTIONFalse1995-04-25DDAVP

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10727da38-afe7-4e45-821b-2ab5ac5a8e5f (view SPL)DDAVP Injection(desmopressin acetate)4 mcg/mLprescriptionHuman PrescriptionSanofi-Aventis U.S. LlcANALYSIS, LABEL, MANUFACTURE, PACK2012-04-091000752451
229df0492-f7ef-47bb-aa67-4ef9e5c2846f (view SPL)DESMOPRESSIN ACETATE Injection4 mcg/mLRx onlyprescriptionHuman PrescriptionAmring Pharmaceuticals Inc.MANUFACTURE, PACK2015-10-121699180901, 699180899
32dc2cec8-6953-4a33-9356-11534fba1fb8 (view SPL)Desmopressin Acetate Injection, USP, 4 mcg/mLprescriptionHuman PrescriptionSun Pharmaceutical Industries LimitedANALYSIS, MANUFACTURE2015-05-072627560529
45fe83452-1670-487d-feb4-27d4bd75a147 (view SPL)Desmopressin Acetate Injection, USPprescriptionHuman PrescriptionHospira, Inc.2014-06-2312004092265
5651f6fee-a2c7-431b-8d5d-58b156c72244 (view SPL)DDAVP Injection(desmopressin acetate)prescriptionHuman PrescriptionFerring Pharmaceuticals Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-12-221555662200, 555662300
6870d88c3-4388-454b-9360-22c582d6bfe1 (view SPL)Desmopressin Acetate InjectionprescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2012-09-073007035051, 007035054
79fd48eec-aa24-4888-b99f-d409ada958a7 (view SPL)Desmopressin Acetate Injection, USP, 4 mcg/mLprescriptionHuman PrescriptionSun Pharmaceutical Industries LimitedANALYSIS, MANUFACTURE2015-05-073627560529
8c7c7ee28-c820-44a2-a441-234c2e43cd18 (view SPL)DesmopressinAcetateInjection, USP 4 mcg/mLprescriptionHuman PrescriptionHospira, Inc.2014-08-281004092265
9fd7672cb-4c15-403c-8e04-68369ad9bb77 (view SPL)DESMOPRESSIN ACETATE Injection4 mcg/mLRx onlyprescriptionHuman PrescriptionFerring Pharmaceuticals Inc.manufacture, pack2010-10-258555665030, 555665040

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