Carbidopa Oral Tablet

Brand(s)
Lodosyn
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Aton Pharma, Inc. (2014-03-04)
Oldest Current Product
2010-04-13
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\CARBIDOPA
FDAOB
ORAL\TABLET\CARBIDOPA
ORAL\TABLET\CARBIDOPA: LEVODOPA
SPL Active
ORAL\TABLET\CARBIDOPA
SPL Moiety
ORAL\TABLET\CARBIDOPA ANHYDROUS

product(s) by strength(s)

carbidopa 25 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1250100711LodosynNDAAton Pharma, Inc.2010-04-13CARBIDOPAORALTABLETNDA017830ff8e105b-7415-42d4-bbb2-b36cfb8945a5

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1439750220ANDAAmerigen Pharmaceuticals Inc.2013-11-01CARBIDOPAORALTABLETANDA203261c47856c9-7013-44a2-b381-4ca67e1d1b4c
2686820200NDA AUTHORIZED GENERICOceanside Pharmaceuticals2014-04-04CARBIDOPAORALTABLETNDA017830d5204e5e-10ef-4758-8fc6-cb710048c687

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790125LodosynNDAKaiser Foundations Hospitals2012-09-25CARBIDOPAORALTABLET250100711NDA01783079e4ca99-7217-41bb-8ace-d0040b56e859
2521250037ANDARemedyrepack Inc.2013-02-27CARBIDOPAORALTABLET000930294ANDA073618dd8d7a75-16e2-4e51-b994-d05fe22f8d4d
3521250078ANDARemedyrepack Inc.2013-03-15CARBIDOPAORALTABLET000930293ANDA0735895bdd7c77-55d8-4652-b3b7-09fd1f40f89d
4521250177ANDARemedyrepack Inc.2013-03-25CARBIDOPAORALTABLET002282540ANDA07426029bae184-0a58-411c-acf0-da5f11535c93

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA073381CARBIDOPA AND LEVODOPATrueWATSON LABORATORIES INC1993-09-28ANDA073381_001Carbidopa / Levodopa Oral Tablet
2ANDA073382CARBIDOPA AND LEVODOPATrueWATSON LABORATORIES INC1993-09-28ANDA073382_001Carbidopa / Levodopa Oral Tablet
3ANDA073383CARBIDOPA AND LEVODOPATrueWATSON LABORATORIES INC1993-09-28ANDA073383_001Carbidopa / Levodopa Oral Tablet
4ANDA073586CARBIDOPA AND LEVODOPATrueSANDOZ INC1995-06-29ANDA073586_001Carbidopa / Levodopa Oral Tablet
5ANDA073587CARBIDOPA AND LEVODOPATrueSANDOZ INC1995-06-29ANDA073587_001Carbidopa / Levodopa Oral Tablet
6ANDA073589CARBIDOPA AND LEVODOPATEVA PHARMACEUTICALS USA INC1992-08-28ANDA073589_001Carbidopa / Levodopa Oral Tablet
7ANDA073607CARBIDOPA AND LEVODOPATEVA PHARMACEUTICALS USA INC1992-08-28ANDA073607_001Carbidopa / Levodopa Oral Tablet
8ANDA073618CARBIDOPA AND LEVODOPATEVA PHARMACEUTICALS USA INC1992-08-28ANDA073618_001Carbidopa / Levodopa Oral Tablet
9ANDA073620CARBIDOPA AND LEVODOPATrueSANDOZ INC1995-06-29ANDA073620_001Carbidopa / Levodopa Oral Tablet
10ANDA074080CARBIDOPA AND LEVODOPATrueSCS PHARMACEUTICALS1994-03-25ANDA074080_001, ANDA074080_002, ANDA074080_003Carbidopa / Levodopa Oral Tablet
11ANDA074260CARBIDOPA AND LEVODOPAACTAVIS ELIZABETH LLC1993-09-03ANDA074260_001, ANDA074260_002, ANDA074260_003Carbidopa / Levodopa Oral Tablet
12ANDA077120CARBIDOPA AND LEVODOPAAPOTEX INC2008-06-02ANDA077120_001, ANDA077120_002, ANDA077120_003Carbidopa / Levodopa Oral Tablet
13ANDA078536CARBIDOPA AND LEVODOPASUN PHARMACEUTICAL INDUSTRIES LTD2008-10-28ANDA078536_001, ANDA078536_002, ANDA078536_003Carbidopa / Levodopa Oral Tablet
14ANDA090324CARBIDOPA AND LEVODOPAMYLAN PHARMACEUTICALS INC2009-09-28ANDA090324_001, ANDA090324_002, ANDA090324_003Carbidopa / Levodopa Oral Tablet
15ANDA203261CARBIDOPAAMERIGEN PHARMACEUTICALS LTD2014-03-10ANDA203261_001
16NDA017555SINEMETMERCK SHARP AND DOHME CORPNDA017555_001, NDA017555_002, NDA017555_003Carbidopa / Levodopa Oral Tablet
17NDA017830LODOSYNATON PHARMA INCNDA017830_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA073381_001discontinuedLEVODOPA (100MG), CARBIDOPA (10MG)ORALTABLETFalse1993-09-28CARBIDOPA AND LEVODOPA
2ANDA073382_001discontinuedCARBIDOPA (25MG), LEVODOPA (100MG)ORALTABLETFalse1993-09-28CARBIDOPA AND LEVODOPA
3ANDA073383_001discontinuedCARBIDOPA (25MG), LEVODOPA (250MG)ORALTABLETFalse1993-09-28CARBIDOPA AND LEVODOPA
4ANDA073586_001discontinuedCARBIDOPA (10MG), LEVODOPA (100MG)ORALTABLETFalse1995-06-29CARBIDOPA AND LEVODOPA
5ANDA073587_001discontinuedCARBIDOPA (25MG), LEVODOPA (100MG)ORALTABLETFalse1995-06-29CARBIDOPA AND LEVODOPA
6ANDA073589_001RXCARBIDOPA (25MG), LEVODOPA (100MG)ORALTABLETFalseAB1992-08-28CARBIDOPA AND LEVODOPA
7ANDA073607_001RXCARBIDOPA (25MG), LEVODOPA (250MG)ORALTABLETFalseAB1992-08-28CARBIDOPA AND LEVODOPA
8ANDA073618_001RXLEVODOPA (100MG), CARBIDOPA (10MG)ORALTABLETFalseAB1992-08-28CARBIDOPA AND LEVODOPA
9ANDA073620_001discontinuedLEVODOPA (250MG), CARBIDOPA (25MG)ORALTABLETFalse1995-06-29CARBIDOPA AND LEVODOPA
10ANDA074080_001discontinuedCARBIDOPA (10MG), LEVODOPA (100MG)ORALTABLETFalse1994-03-25CARBIDOPA AND LEVODOPA
11ANDA074080_002discontinuedCARBIDOPA (25MG), LEVODOPA (100MG)ORALTABLETFalse1994-03-25CARBIDOPA AND LEVODOPA
12ANDA074080_003discontinuedCARBIDOPA (25MG), LEVODOPA (250MG)ORALTABLETFalse1994-03-25CARBIDOPA AND LEVODOPA
13ANDA074260_001RXCARBIDOPA (10MG), LEVODOPA (100MG)ORALTABLETFalseAB1993-09-03CARBIDOPA AND LEVODOPA
14ANDA074260_002RXLEVODOPA (100MG), CARBIDOPA (25MG)ORALTABLETFalseAB1993-09-03CARBIDOPA AND LEVODOPA
15ANDA074260_003RXLEVODOPA (250MG), CARBIDOPA (25MG)ORALTABLETFalseAB1993-09-03CARBIDOPA AND LEVODOPA
16ANDA077120_001RXLEVODOPA (100MG), CARBIDOPA (10MG)ORALTABLETFalseAB2008-06-02CARBIDOPA AND LEVODOPA
17ANDA077120_002RXLEVODOPA (100MG), CARBIDOPA (25MG)ORALTABLETFalseAB2008-06-02CARBIDOPA AND LEVODOPA
18ANDA077120_003RXCARBIDOPA (25MG), LEVODOPA (250MG)ORALTABLETFalseAB2008-06-02CARBIDOPA AND LEVODOPA
19ANDA078536_001RXCARBIDOPA (10MG), LEVODOPA (100MG)ORALTABLETFalseAB2008-10-28CARBIDOPA AND LEVODOPA
20ANDA078536_002RXCARBIDOPA (25MG), LEVODOPA (100MG)ORALTABLETFalseAB2008-10-28CARBIDOPA AND LEVODOPA
21ANDA078536_003RXLEVODOPA (250MG), CARBIDOPA (25MG)ORALTABLETFalseAB2008-10-28CARBIDOPA AND LEVODOPA
22ANDA090324_001RXCARBIDOPA (10MG), LEVODOPA (100MG)ORALTABLETFalseAB2009-09-28CARBIDOPA AND LEVODOPA
23ANDA090324_002RXCARBIDOPA (25MG), LEVODOPA (100MG)ORALTABLETFalseAB2009-09-28CARBIDOPA AND LEVODOPA
24ANDA090324_003RXCARBIDOPA (25MG), LEVODOPA (250MG)ORALTABLETFalseAB2009-09-28CARBIDOPA AND LEVODOPA
25ANDA203261_001RXCARBIDOPA (25MG)ORALTABLETFalseAB2014-03-10CARBIDOPA
26NDA017555_001RXLEVODOPA (100MG), CARBIDOPA (10MG)ORALTABLETFalseABSINEMET
27NDA017555_002RXCARBIDOPA (25MG), LEVODOPA (250MG)ORALTABLETTrueABSINEMET
28NDA017555_003RXCARBIDOPA (25MG), LEVODOPA (100MG)ORALTABLETFalseABSINEMET
29NDA017830_001RXCARBIDOPA (25MG)ORALTABLETTrueABLODOSYN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
129bae184-0a58-411c-acf0-da5f11535c93 (view SPL)CARBIDOPA and LEVODOPA TABLETS, USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-03-251521250177
25bdd7c77-55d8-4652-b3b7-09fd1f40f89d (view SPL)CARBIDOPA AND LEVODOPA TABLETS USP029202930294Rx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2013-03-151521250078
379e4ca99-7217-41bb-8ace-d0040b56e859 (view SPL)LODOSYN (CARBIDOPA) TABLETSprescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2012-09-251001790125
4c47856c9-7013-44a2-b381-4ca67e1d1b4c (view SPL)Carbidopa Tablets, 25 mgprescriptionHuman PrescriptionAmerigen Pharmaceuticals Inc.MANUFACTURE2014-03-182439750220
5d5204e5e-10ef-4758-8fc6-cb710048c687 (view SPL)CARBIDOPA TABLETSprescriptionHuman PrescriptionOceanside PharmaceuticalsMANUFACTURE2014-06-015686820200
6dd8d7a75-16e2-4e51-b994-d05fe22f8d4d (view SPL)CARBIDOPA AND LEVODOPA TABLETS USP029202930294Rx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2013-02-272521250037
7ff8e105b-7415-42d4-bbb2-b36cfb8945a5 (view SPL)LODOSYN (CARBIDOPA) TABLETSprescriptionHuman PrescriptionAton Pharma, Inc.MANUFACTURE2014-03-043250100711

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