FDA.reportPublic FDA data

Application 020796

Type
NDA
Sponsor
ORION PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COMTANENTACAPONETABLET;ORAL200MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0327ComtanentacaponeNovartis Pharmaceuticals CorporationNDACurrent
0078-0327ComtanentacaponeNovartis Pharmaceuticals CorporationNDACurrent
0078-0327ComtanentacaponeNovartis Pharmaceuticals CorporationNDACurrent
0378-9080EntacaponeEntacaponeMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-9080EntacaponeEntacaponeMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0781-5578EntacaponeEntacaponeSandoz IncNDA AUTHORIZED GENERICCurrent
0781-5578EntacaponeEntacaponeSandoz IncNDA AUTHORIZED GENERICCurrent
43353-996EntacaponeEntacaponeAphena Pharma Solutions - Tennessee, LLCNDACurrent
43353-996EntacaponeEntacaponeAphena Pharma Solutions - Tennessee, LLCNDACurrent
47335-007EntacaponeEntacaponeSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
51079-273EntacaponeEntacaponeMylan Institutional Inc.NDA AUTHORIZED GENERICCurrent
51079-273EntacaponeEntacaponeMylan Institutional Inc.NDA AUTHORIZED GENERICCurrent
51079-273EntacaponeEntacaponeMylan Institutional Inc.NDA AUTHORIZED GENERICCurrent
52427-800ComtanentacaponeAlmatica Pharma LLCNDACurrent
52427-800ComtanentacaponeAlmatica Pharma LLCNDACurrent
52427-800ComtanentacaponeAlmatica Pharma LLCNDACurrent
55648-290EntacaponeEntacaponeWockhardt LimitedNDA AUTHORIZED GENERICCurrent
55648-781EntacaponeEntacaponeWockhardt LimitedNDA AUTHORIZED GENERICCurrent
64679-290EntacaponeEntacaponeWockhardt USA LLC.NDA AUTHORIZED GENERICCurrent
64679-781EntacaponeEntacaponeWockhardt USA LLC.NDACurrent
64679-781EntacaponeEntacaponeWockhardt USA LLC.NDACurrent
64679-781EntacaponeEntacaponeWockhardt USA LLC.NDACurrent
71610-247EntacaponeEntacaponeAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
13455SUPPL2016-02-26
3385SUPPL2016-02-24
25858SUPPL2015-01-20
13454SUPPL2015-01-20
13453SUPPL2014-06-17
3384SUPPL2014-06-17
3383SUPPL2010-10-13
35384SUPPL2010-10-11
13452SUPPL2009-02-04
13451SUPPL2009-02-04
25857SUPPL2009-02-03
3382SUPPL2009-02-03
25856ORIG1999-12-30
20965ORIG1999-12-30
13450ORIG1999-12-30