Application 220119

Type
ANDA
Sponsor
BIOCON PHARMA LIMITED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002CARBIDOPA AND LEVODOPACARBIDOPA,LEVODOPACAPSULE, EXTENDED RELEASE145MGNoNo
003CARBIDOPA AND LEVODOPACARBIDOPA,LEVODOPACAPSULE, EXTENDED RELEASE23.75MGNoNo
004CARBIDOPA AND LEVODOPACARBIDOPA,LEVODOPACAPSULE, EXTENDED RELEASE95MGNoNo
005CARBIDOPA AND LEVODOPACARBIDOPA,LEVODOPACAPSULE, EXTENDED RELEASE245MGNoNo
006CARBIDOPA AND LEVODOPACARBIDOPA,LEVODOPACAPSULE, EXTENDED RELEASE61.25MGNoNo
007CARBIDOPA AND LEVODOPACARBIDOPA,LEVODOPACAPSULE, EXTENDED RELEASE48.75MGNoNo
008CARBIDOPA AND LEVODOPACARBIDOPA,LEVODOPACAPSULE, EXTENDED RELEASE195MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 3 · 58 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Carbidopa and LevodopaCARBIDOPA AND LEVODOPABryant Ranch Prepack3b06a0e2-bec8-4178-942b-67eb47f2916e2026-07-16Warnings, Adverse reactionsName fallback
brand name: Carbidopa and Levodopa
Carbidopa and LevodopaCARBIDOPA AND LEVODOPABryant Ranch Prepack043e58c6-092d-4637-90f1-9d36af143a242026-07-16Warnings, Adverse reactionsName fallback
brand name: Carbidopa and Levodopa
Carbidopa and LevodopaCARBIDOPA AND LEVODOPACoupler LLC5682a705-de0e-6b70-e063-6394a90aadfb2026-07-13Warnings, Adverse reactionsName fallback
brand name: Carbidopa and Levodopa
CARBIDOPA AND LEVODOPACARBIDOPA AND LEVODOPAAphena Pharma Solutions - Tennessee, LLC5644d10f-620e-810e-e063-6294a90af6782026-07-10Warnings, Adverse reactionsName fallback
brand name: CARBIDOPA AND LEVODOPA
Carbidopa and levodopaCARBIDOPA AND LEVODOPATeva Pharmaceuticals USA, Inc.4ace5274-b6cf-414c-b9c0-f60e28a9cea52026-07-09Warnings, Adverse reactionsName fallback
brand name: Carbidopa and levodopa
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAAvPAK54f30abc-97fa-00f0-e063-6394a90a155d2026-06-23Warnings, Adverse reactionsName fallback
brand name: Carbidopa and Levodopa
Carbidopa and LevodopaCARBIDOPA AND LEVODOPARadha Pharmaceuticals Inc33a22ffe-0d41-162d-e063-6394a90a43d32026-06-22Warnings, Adverse reactionsName fallback
brand name: Carbidopa and Levodopa
CARBIDOPA AND LEVODOPACARBIDOPA AND LEVODOPASun Pharmaceutical Industries, Inc.48e0f2ec-b217-4c25-a71c-20e173d05edb2026-06-12Warnings, Adverse reactionsName fallback
brand name: CARBIDOPA AND LEVODOPA
CARBIDOPA AND LEVODOPACARBIDOPA AND LEVODOPASun Pharmaceutical Industries, Inc.d2a64f14-f638-49d9-8a96-cb7ae46ac3ea2026-06-04Warnings, Adverse reactionsName fallback
brand name: CARBIDOPA AND LEVODOPA
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAScieGen Pharmaceuticals Inc1b17ab1e-f3c1-4343-ba28-e2901cd97d432026-06-01Warnings, Adverse reactionsName fallback
brand name: Carbidopa and Levodopa
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAMajor Pharmaceuticals3f6d393e-ac84-4a3c-a837-199d1ec71fd22026-05-28Warnings, Adverse reactionsName fallback
brand name: Carbidopa and Levodopa
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAWestminster Pharmaceuticals, LLC3f026272-32a6-4c98-8b6f-d910c7f58aa22026-05-27Warnings, Adverse reactionsName fallback
brand name: Carbidopa and Levodopa
Carbidopa and LevodopaCARBIDOPA AND LEVODOPADr. Reddy's Laboratories Inc87ab55c9-203d-d595-3e3e-0e38f2f6d9c42026-05-19Warnings, Adverse reactionsName fallback
brand name: Carbidopa and Levodopa
Carbidopa and levodopaCARBIDOPA AND LEVODOPAAdvagen Pharma Ltd5b6519ff-d1af-402b-83eb-b4fce6743a182026-05-12Warnings, Adverse reactionsName fallback
brand name: Carbidopa and levodopa
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAREMEDYREPACK INC.4ce99f65-5857-448c-b22a-9b3b64de69e22026-04-29Warnings, Adverse reactionsName fallback
brand name: Carbidopa and Levodopa
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAScieGen Pharmaceuticals Inca32afa84-7bc0-4bd3-bc50-55d738f3d7ce2026-04-27Warnings, Adverse reactionsName fallback
brand name: Carbidopa and Levodopa
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAMylan Pharmaceuticals Inc.aa5028d6-fd0a-4cf1-b708-c93bb2a7c76a2026-04-24Warnings, Adverse reactionsName fallback
brand name: Carbidopa and Levodopa
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAREMEDYREPACK INC.b29e58f0-67b1-4036-a4a8-4915a8c13cdf2026-04-24Warnings, Adverse reactionsName fallback
brand name: Carbidopa and Levodopa
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAREMEDYREPACK INC.beedd327-bbc5-4f17-838a-4e72bf0867f02026-04-24Warnings, Adverse reactionsName fallback
brand name: Carbidopa and Levodopa
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAREMEDYREPACK INC.57688b2c-7be0-4e73-9b4f-7ec3b5dc1c372026-04-24Warnings, Adverse reactionsName fallback
brand name: Carbidopa and Levodopa