FDA.reportPublic FDA data

Application 021485

Type
NDA
Sponsor
ORION PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001STALEVO 50CARBIDOPA; ENTACAPONE; LEVODOPATABLET;ORAL12.5MG;200MG;50MGYesYes
002STALEVO 100CARBIDOPA; ENTACAPONE; LEVODOPATABLET;ORAL25MG;200MG;100MGYesNo
003STALEVO 150CARBIDOPA; ENTACAPONE; LEVODOPATABLET;ORAL37.5MG;200MG;150MGYesNo
004STALEVO 200CARBIDOPA; ENTACAPONE; LEVODOPATABLET;ORAL50MG;200MG;200MGYesYes
005STALEVO 75CARBIDOPA; ENTACAPONE; LEVODOPATABLET;ORAL18.75MG;200MG;75MGYesNo
006STALEVO 125CARBIDOPA; ENTACAPONE; LEVODOPATABLET;ORAL31.25MG;200MG;125MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0407Stalevocarbidopa, levodopa, and entacaponeNovartis Pharmaceuticals CorporationNDACurrent
0078-0407Stalevocarbidopa, levodopa, and entacaponeNovartis Pharmaceuticals CorporationNDACurrent
0078-0407Stalevocarbidopa, levodopa, and entacaponeNovartis Pharmaceuticals CorporationNDACurrent
0078-0407Stalevocarbidopa, levodopa, and entacaponeNovartis Pharmaceuticals CorporationNDACurrent
0078-0408Stalevocarbidopa, levodopa, and entacaponeNovartis Pharmaceuticals CorporationNDACurrent
0078-0408Stalevocarbidopa, levodopa, and entacaponeNovartis Pharmaceuticals CorporationNDACurrent
0078-0408Stalevocarbidopa, levodopa, and entacaponeNovartis Pharmaceuticals CorporationNDACurrent
0078-0408Stalevocarbidopa, levodopa, and entacaponeNovartis Pharmaceuticals CorporationNDACurrent
0078-0409Stalevocarbidopa, levodopa, and entacaponeNovartis Pharmaceuticals CorporationNDACurrent
0078-0409Stalevocarbidopa, levodopa, and entacaponeNovartis Pharmaceuticals CorporationNDACurrent
0078-0409Stalevocarbidopa, levodopa, and entacaponeNovartis Pharmaceuticals CorporationNDACurrent
0078-0409Stalevocarbidopa, levodopa, and entacaponeNovartis Pharmaceuticals CorporationNDACurrent
0078-0527Stalevocarbidopa, levodopa, and entacaponeNovartis Pharmaceuticals CorporationNDACurrent
0078-0527Stalevocarbidopa, levodopa, and entacaponeNovartis Pharmaceuticals CorporationNDACurrent
0078-0527Stalevocarbidopa, levodopa, and entacaponeNovartis Pharmaceuticals CorporationNDACurrent
0078-0527Stalevocarbidopa, levodopa, and entacaponeNovartis Pharmaceuticals CorporationNDACurrent
0078-0544Stalevocarbidopa, levodopa, and entacaponeNovartis Pharmaceuticals CorporationNDACurrent
0078-0544Stalevocarbidopa, levodopa, and entacaponeNovartis Pharmaceuticals CorporationNDACurrent
0078-0544Stalevocarbidopa, levodopa, and entacaponeNovartis Pharmaceuticals CorporationNDACurrent
0078-0544Stalevocarbidopa, levodopa, and entacaponeNovartis Pharmaceuticals CorporationNDACurrent
0078-0545Stalevocarbidopa, levodopa, and entacaponeNovartis Pharmaceuticals CorporationNDACurrent
0078-0545Stalevocarbidopa, levodopa, and entacaponeNovartis Pharmaceuticals CorporationNDACurrent
0078-0545Stalevocarbidopa, levodopa, and entacaponeNovartis Pharmaceuticals CorporationNDACurrent
0078-0545Stalevocarbidopa, levodopa, and entacaponeNovartis Pharmaceuticals CorporationNDACurrent
0378-8300Carbidopa, Levodopa and Entacaponecarbidopa, levodopa and entacaponeMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8301Carbidopa, Levodopa and Entacaponecarbidopa, levodopa and entacaponeMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8302Carbidopa, Levodopa and Entacaponecarbidopa, levodopa and entacaponeMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8302Carbidopa, Levodopa and Entacaponecarbidopa, levodopa and entacaponeMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8302Carbidopa, Levodopa and Entacaponecarbidopa, levodopa and entacaponeMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8303Carbidopa, Levodopa and Entacaponecarbidopa, levodopa and entacaponeMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8303Carbidopa, Levodopa and Entacaponecarbidopa, levodopa and entacaponeMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8303Carbidopa, Levodopa and Entacaponecarbidopa, levodopa and entacaponeMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8304Carbidopa, Levodopa and Entacaponecarbidopa, levodopa and entacaponeMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8304Carbidopa, Levodopa and Entacaponecarbidopa, levodopa and entacaponeMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8305Carbidopa, Levodopa and Entacaponecarbidopa, levodopa and entacaponeMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8305Carbidopa, Levodopa and Entacaponecarbidopa, levodopa and entacaponeMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8305Carbidopa, Levodopa and Entacaponecarbidopa, levodopa and entacaponeMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0781-5613Carbidopa, Levodopa, and EntacaponeCarbidopa, Levodopa, and EntacaponeSandoz IncNDA AUTHORIZED GENERICCurrent
0781-5613Carbidopa, Levodopa, and EntacaponeCarbidopa, Levodopa, and EntacaponeSandoz IncNDA AUTHORIZED GENERICCurrent
0781-5625Carbidopa, Levodopa, and EntacaponeCarbidopa, Levodopa, and EntacaponeSandoz IncNDA AUTHORIZED GENERICCurrent
0781-5625Carbidopa, Levodopa, and EntacaponeCarbidopa, Levodopa, and EntacaponeSandoz IncNDA AUTHORIZED GENERICCurrent
0781-5637Carbidopa, Levodopa, and EntacaponeCarbidopa, Levodopa, and EntacaponeSandoz IncNDA AUTHORIZED GENERICCurrent
0781-5637Carbidopa, Levodopa, and EntacaponeCarbidopa, Levodopa, and EntacaponeSandoz IncNDA AUTHORIZED GENERICCurrent
0781-5641Carbidopa, Levodopa, and EntacaponeCarbidopa, Levodopa, and EntacaponeSandoz IncNDA AUTHORIZED GENERICCurrent
0781-5641Carbidopa, Levodopa, and EntacaponeCarbidopa, Levodopa, and EntacaponeSandoz IncNDA AUTHORIZED GENERICCurrent
0781-5654Carbidopa, Levodopa, and EntacaponeCarbidopa, Levodopa, and EntacaponeSandoz IncNDA AUTHORIZED GENERICCurrent
0781-5654Carbidopa, Levodopa, and EntacaponeCarbidopa, Levodopa, and EntacaponeSandoz IncNDA AUTHORIZED GENERICCurrent
0781-5669Carbidopa, Levodopa, and EntacaponeCarbidopa, Levodopa, and EntacaponeSandoz IncNDA AUTHORIZED GENERICCurrent
0781-5669Carbidopa, Levodopa, and EntacaponeCarbidopa, Levodopa, and EntacaponeSandoz IncNDA AUTHORIZED GENERICCurrent
47335-001Carbidopa, levodopa and entacaponeCarbidopa, levodopa and entacaponeSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
47335-002Carbidopa, levodopa and entacaponeCarbidopa, levodopa and entacaponeSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
47335-003Carbidopa, levodopa and entacaponeCarbidopa, levodopa and entacaponeSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
47335-004Carbidopa, levodopa and entacaponeCarbidopa, levodopa and entacaponeSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
47335-005Carbidopa, levodopa and entacaponeCarbidopa, levodopa and entacaponeSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
47335-006Carbidopa, levodopa and entacaponeCarbidopa, levodopa and entacaponeSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
52427-805Stalevocarbidopa, levodopa, and entacaponeAlmatica Pharma LLCNDACurrent
52427-805Stalevocarbidopa, levodopa, and entacaponeAlmatica Pharma LLCNDACurrent
52427-805Stalevocarbidopa, levodopa, and entacaponeAlmatica Pharma LLCNDACurrent
52427-809Stalevocarbidopa, levodopa, and entacaponeAlmatica Pharma LLCNDACurrent
52427-809Stalevocarbidopa, levodopa, and entacaponeAlmatica Pharma LLCNDACurrent
52427-809Stalevocarbidopa, levodopa, and entacaponeAlmatica Pharma LLCNDACurrent
52427-816Stalevocarbidopa, levodopa, and entacaponeAlmatica Pharma LLCNDACurrent
52427-816Stalevocarbidopa, levodopa, and entacaponeAlmatica Pharma LLCNDACurrent
52427-816Stalevocarbidopa, levodopa, and entacaponeAlmatica Pharma LLCNDACurrent
52427-827Stalevocarbidopa, levodopa, and entacaponeAlmatica Pharma LLCNDACurrent
52427-827Stalevocarbidopa, levodopa, and entacaponeAlmatica Pharma LLCNDACurrent
52427-827Stalevocarbidopa, levodopa, and entacaponeAlmatica Pharma LLCNDACurrent
52427-834Stalevocarbidopa, levodopa, and entacaponeAlmatica Pharma LLCNDACurrent
52427-834Stalevocarbidopa, levodopa, and entacaponeAlmatica Pharma LLCNDACurrent
52427-834Stalevocarbidopa, levodopa, and entacaponeAlmatica Pharma LLCNDACurrent
52427-842Stalevocarbidopa, levodopa, and entacaponeAlmatica Pharma LLCNDACurrent
52427-842Stalevocarbidopa, levodopa, and entacaponeAlmatica Pharma LLCNDACurrent
52427-842Stalevocarbidopa, levodopa, and entacaponeAlmatica Pharma LLCNDACurrent
55648-782carbidopa, levodopa and entacaponecarbidopa, levodopa and entacaponeWockhardt LimitedNDA AUTHORIZED GENERICCurrent
55648-783carbidopa, levodopa and entacaponecarbidopa, levodopa and entacaponeWockhardt LimitedNDA AUTHORIZED GENERICCurrent
55648-784carbidopa, levodopa and entacaponecarbidopa, levodopa and entacaponeWockhardt LimitedNDA AUTHORIZED GENERICCurrent
55648-785carbidopa, levodopa and entacaponecarbidopa, levodopa and entacaponeWockhardt LimitedNDA AUTHORIZED GENERICCurrent
55648-786carbidopa, levodopa and entacaponecarbidopa, levodopa and entacaponeWockhardt LimitedNDA AUTHORIZED GENERICCurrent
55648-787carbidopa, levodopa and entacaponecarbidopa, levodopa and entacaponeWockhardt LimitedNDA AUTHORIZED GENERICCurrent
64679-782CARBIDOPA, LEVODOPA AND ENTACAPONEcarbidopa, levodopa and entacaponeWockhardt USA LLC.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85497SUPPL 2026-03-24
85445SUPPL 2026-03-23
61518SUPPL2020-01-06
61482SUPPL2019-12-31
55930SUPPL2018-10-15
55736SUPPL2018-10-01
15581SUPPL2016-02-25
5518SUPPL2016-02-24
15582SUPPL2016-02-23
27910SUPPL2014-07-24
5517SUPPL2014-07-24
37052SUPPL2014-07-23
37051SUPPL2014-07-23
5516SUPPL2010-10-13
15580SUPPL2010-10-11
44127ORIG2010-08-09
37048SUPPL2009-03-23
15578SUPPL2009-03-23
27907SUPPL2009-03-05
5512SUPPL2009-03-05
37047SUPPL2009-02-04
15577SUPPL2009-02-04
27908SUPPL2009-02-03
5513SUPPL2009-02-03
37050SUPPL2008-10-03
5515SUPPL2008-10-01
5514SUPPL2008-09-03
37049SUPPL2008-08-29
27909SUPPL2007-08-07
15579SUPPL2007-08-03
21686ORIG2004-03-24
15576ORIG2003-06-22
5511ORIG2003-06-22