desmopressin Oral Tablet

Brand(s)
DDAVP
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Bluepoint Laboratories (2015-09-28)
Oldest Current Product
1995-09-06
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\DESMOPRESSIN
FDAOB
ORAL\TABLET\DESMOPRESSIN ACETATE
SPL Active
ORAL\TABLET\DESMOPRESSIN ACETATE
SPL Moiety
ORAL\TABLET\DESMOPRESSIN

product(s) by strength(s)

desmopressin acetate 0.1 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1555662600DDAVPNDAFerring Pharmaceuticals Inc.1995-09-06DESMOPRESSIN ACETATEORALTABLETNDA0199556d55baa9-2b62-469c-93ae-3909ab249332
2555665060NDAFerring Pharmaceuticals Inc.2008-05-05DESMOPRESSIN ACETATEORALTABLETNDA02179536d2d6cf-058f-64f0-0a31-de81328c8b54
3680010233Bluepoint LaboratoriesDESMOPRESSIN ACETATEORALTABLET336886d5-2dc6-41c6-bee9-9172f89ff604

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937316ANDATeva Pharmaceuticals Usa Inc2006-01-27DESMOPRESSIN ACETATEORALTABLETANDA0771224f988a1e-4867-496f-af77-9c4d07a02b3c
2005912464ANDAWatson Laboratories, Inc.2011-08-15DESMOPRESSIN ACETATEORALTABLETANDA07647043bd65ca-0b1c-42c9-bbcd-7a97d3287581
3605050257ANDAApotex Corp2006-03-07DESMOPRESSIN ACETATEORALTABLETANDA07741472aeef35-c102-b628-0219-9822651887eb
4684620275ANDAGlenmark Generics Inc., Usa2015-05-28DESMOPRESSIN ACETATEORALTABLETANDA2018317a26b415-77cd-4b2f-9c76-fa52d2eb6be6

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1502680220ANDAAvpak2013-07-24DESMOPRESSIN ACETATEORALTABLET005912464ANDA0764703956df8d-21bb-0478-0a36-cce61e115c88
2606870109ANDAAmerican Health Packaging2015-09-15DESMOPRESSIN ACETATEORALTABLET680010233ANDA076470a13b1439-215c-4305-aa26-4fc8469e298e
3680840606ANDAAmerican Health Packaging2012-10-08DESMOPRESSIN ACETATEORALTABLET005912464ANDA076470043be50e-73b5-45bf-9316-776d4f675170
4681511281ANDACarilion Materials Management2006-01-27DESMOPRESSIN ACETATEORALTABLET000937316ANDA0771227954af2c-9c93-4e6d-8814-494aa7b965ad

desmopressin acetate 0.2 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1555662700DDAVPNDAFerring Pharmaceuticals Inc.1995-09-06DESMOPRESSIN ACETATEORALTABLETNDA0199556d55baa9-2b62-469c-93ae-3909ab249332
2555665061NDAFerring Pharmaceuticals Inc.2008-05-05DESMOPRESSIN ACETATEORALTABLETNDA02179536d2d6cf-058f-64f0-0a31-de81328c8b54
3680010234Bluepoint LaboratoriesDESMOPRESSIN ACETATEORALTABLET336886d5-2dc6-41c6-bee9-9172f89ff604

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937317ANDATeva Pharmaceuticals Usa Inc2006-01-27DESMOPRESSIN ACETATEORALTABLETANDA0771224f988a1e-4867-496f-af77-9c4d07a02b3c
2005912465ANDAWatson Laboratories, Inc.2011-08-15DESMOPRESSIN ACETATEORALTABLETANDA07647043bd65ca-0b1c-42c9-bbcd-7a97d3287581
3510790446ANDAMylan Institutional Inc.2007-12-26DESMOPRESSIN ACETATEORALTABLETANDA0771220a80f111-dc53-4907-9b50-c29015555f12
4605050258ANDAApotex Corp2006-03-07DESMOPRESSIN ACETATEORALTABLETANDA07741472aeef35-c102-b628-0219-9822651887eb
5684620276ANDAGlenmark Generics Inc., Usa2015-05-28DESMOPRESSIN ACETATEORALTABLETANDA2018317a26b415-77cd-4b2f-9c76-fa52d2eb6be6

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006157549ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2011-01-17DESMOPRESSIN ACETATEORALTABLET000937317ANDA0771223b937515-0f54-432c-a2bb-793a433719d8
2502680221ANDAAvpak2013-07-24DESMOPRESSIN ACETATEORALTABLET005912465ANDA0764703956df8d-21bb-0478-0a36-cce61e115c88
3548681129ANDAPhysicians Total Care, Inc.2007-07-19DESMOPRESSIN ACETATEORALTABLET00093731701ANDA07712223fc71d7-0367-4e71-848a-ed72957bd230
4606870120ANDAAmerican Health Packaging2015-09-15DESMOPRESSIN ACETATEORALTABLET680010234ANDA076470a13b1439-215c-4305-aa26-4fc8469e298e
5636294816ANDABryant Ranch Prepack2011-08-15DESMOPRESSIN ACETATEORALTABLET005912465ANDA0764701ba138b6-5e63-401b-9d9c-b430e1c76f37
6680840604ANDAAmerican Health Packaging2012-10-08DESMOPRESSIN ACETATEORALTABLET005912465ANDA076470043be50e-73b5-45bf-9316-776d4f675170

application(s)

#idtitleapplicantapprovedexclusivityapproved drug
1ANDA076470DESMOPRESSIN ACETATEACTAVIS LABORATORIES FL INC2005-07-01ANDA076470_001, ANDA076470_002
2ANDA077122DESMOPRESSIN ACETATETEVA PHARMACEUTICALS USA2006-01-25ANDA077122_001, ANDA077122_002
3ANDA077414DESMOPRESSIN ACETATEAPOTEX INC ETOBICOKE SITE2006-03-07ANDA077414_001, ANDA077414_002
4ANDA200653DESMOPRESSIN ACETATEMYLAN PHARMACEUTICALS INC2014-06-27PATENT CHALLENGE [2015-05-16]ANDA200653_001, ANDA200653_002
5ANDA201831DESMOPRESSIN ACETATEGLENMARK PHARMACEUTICALS LTD2015-05-28ANDA201831_001, ANDA201831_002
6NDA019955DDAVPFERRING PHARMACEUTICALS INC1995-09-06NDA019955_001, NDA019955_002
7NDA021795DESMOPRESSIN ACETATEFERRING PHARMACEUTICALS INC2008-05-08NDA021795_001, NDA021795_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076470_001RXDESMOPRESSIN ACETATE (0.1MG)ORALTABLETFalseAB2005-07-01DESMOPRESSIN ACETATE
2ANDA076470_002RXDESMOPRESSIN ACETATE (0.2MG)ORALTABLETFalseAB2005-07-01DESMOPRESSIN ACETATE
3ANDA077122_001RXDESMOPRESSIN ACETATE (0.1MG)ORALTABLETFalseAB2006-01-25DESMOPRESSIN ACETATE
4ANDA077122_002RXDESMOPRESSIN ACETATE (0.2MG)ORALTABLETFalseAB2006-01-25DESMOPRESSIN ACETATE
5ANDA077414_001RXDESMOPRESSIN ACETATE (0.1MG)ORALTABLETFalseAB2006-03-07DESMOPRESSIN ACETATE
6ANDA077414_002RXDESMOPRESSIN ACETATE (0.2MG)ORALTABLETFalseAB2006-03-07DESMOPRESSIN ACETATE
7ANDA200653_001RXDESMOPRESSIN ACETATE (0.1MG)ORALTABLETFalseAB2014-06-27DESMOPRESSIN ACETATE
8ANDA200653_002RXDESMOPRESSIN ACETATE (0.2MG)ORALTABLETFalseAB2014-06-27DESMOPRESSIN ACETATE
9ANDA201831_001RXDESMOPRESSIN ACETATE (0.1MG)ORALTABLETFalseAB2015-05-28DESMOPRESSIN ACETATE
10ANDA201831_002RXDESMOPRESSIN ACETATE (0.2MG)ORALTABLETFalseAB2015-05-28DESMOPRESSIN ACETATE
11NDA019955_001RXDESMOPRESSIN ACETATE (0.1MG)ORALTABLETFalseAB1995-09-06DDAVP
12NDA019955_002RXDESMOPRESSIN ACETATE (0.2MG)ORALTABLETTrueAB1995-09-06DDAVP
13NDA021795_001RXDESMOPRESSIN ACETATE (0.1MG)ORALTABLETFalse2008-05-08DESMOPRESSIN ACETATE
14NDA021795_002RXDESMOPRESSIN ACETATE (0.2MG)ORALTABLETTrue2008-05-08DESMOPRESSIN ACETATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1043be50e-73b5-45bf-9316-776d4f675170 (view SPL)Desmopressin Acetate TabletsprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-07-223680840604, 680840606
20a80f111-dc53-4907-9b50-c29015555f12 (view SPL)DESMOPRESSIN ACETATE TABLETS, 0.1 mg and 0.2 mg Rx onlyprescriptionHuman PrescriptionMylan Institutional Inc.2013-02-012510790446
31ba138b6-5e63-401b-9d9c-b430e1c76f37 (view SPL)DESMOPRESSIN ACETATE TABLETSprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-181000636294816
41bb9b8d5-eed6-45cb-b1b9-e43d3ee6fecd (view SPL)DDAVP Tablets(desmopressin acetate)prescriptionHuman PrescriptionSanofi-Aventis U.S. LlcMANUFACTURE2009-09-015000750016, 000750026
523fc71d7-0367-4e71-848a-ed72957bd230 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2011-01-121548681129
6336886d5-2dc6-41c6-bee9-9172f89ff604 (view SPL)DESMOPRESSIN ACETATE TABLETSprescriptionHuman PrescriptionBluepoint LaboratoriesANALYSIS, LABEL, MANUFACTURE, PACK2015-09-285680010233, 680010234
736d2d6cf-058f-64f0-0a31-de81328c8b54 (view SPL)Desmopressin Acetate TabletsprescriptionHuman PrescriptionFerring Pharmaceuticals Inc.manufacture, pack2014-07-033555665060, 555665061
83956df8d-21bb-0478-0a36-cce61e115c88 (view SPL)DESMOPRESSIN ACETATE TABLETSprescriptionHuman PrescriptionAvpak2014-09-232502680220, 502680221
93b937515-0f54-432c-a2bb-793a433719d8 (view SPL)DESMOPRESSIN ACETATE TABLETS, 0.1 mg and 0.2 mg73167317Rx onlyprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2011-02-181006157549
1043bd65ca-0b1c-42c9-bbcd-7a97d3287581 (view SPL)DESMOPRESSIN ACETATE TABLETSprescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-09-014005912464, 005912465
114f988a1e-4867-496f-af77-9c4d07a02b3c (view SPL)DESMOPRESSIN ACETATE TABLETS, 0.1 mg and 0.2 mg73167317Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-05-126000937316, 000937317
126d55baa9-2b62-469c-93ae-3909ab249332 (view SPL)DDAVP Tablets(desmopressin acetate)prescriptionHuman PrescriptionFerring Pharmaceuticals Inc.ANALYSIS, MANUFACTURE, PACK2014-12-191555662600, 555662700
1372aeef35-c102-b628-0219-9822651887eb (view SPL)Desmporessin Acetate Tablets 0.1 mg, 0.2 mgprescriptionHuman PrescriptionApotex Corpanalysis, manufacture2013-04-093605050257, 605050258
147954af2c-9c93-4e6d-8814-494aa7b965ad (view SPL)DESMOPRESSIN ACETATE TABLETS, 0.1 mg and 0.2 mg 7316 7317 Rx onlyprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2012-08-022681511281
157a26b415-77cd-4b2f-9c76-fa52d2eb6be6 (view SPL)Desmopressin Acetate Tablets, 0.1 mg and 0.2 mgprescriptionHuman PrescriptionGlenmark Generics Inc., UsaANALYSIS, MANUFACTURE2015-06-232684620275, 684620276
16a13b1439-215c-4305-aa26-4fc8469e298e (view SPL)Desmopressin Acetate TabletsprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-08-251606870109, 606870120
17c01048e8-d28f-4085-9c37-3d5d48395a77 (view SPL)Desmopressin Acetate TabletsprescriptionHuman PrescriptionAmring Pharmaceuticals Inc.MANUFACTURE, PACK2015-10-051699180101, 699180201

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