FDA.reportPublic FDA data

Application 040861

Type
ANDA
Sponsor
MIKART

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHLORZOXAZONECHLORZOXAZONETABLET;ORAL375MGNoYes
002CHLORZOXAZONECHLORZOXAZONETABLET;ORAL750MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13811-717chlorzoxazonechlorzoxazoneTrigen Laboratories, LLCANDACurrent
13811-717chlorzoxazonechlorzoxazoneTrigen Laboratories, LLCANDACurrent
13811-718chlorzoxazonechlorzoxazoneTrigen Laboratories, LLCANDACurrent
13811-718chlorzoxazonechlorzoxazoneTrigen Laboratories, LLCANDACurrent
46672-117chlorzoxazonechlorzoxazoneMikart Inc.ANDACurrent
46672-117chlorzoxazonechlorzoxazoneMikart, LLCANDACurrent
46672-118chlorzoxazonechlorzoxazoneMikart Inc.ANDACurrent
46672-118chlorzoxazonechlorzoxazoneMikart, LLCANDACurrent
55700-517LorzonechlorzoxazoneLake Erie Medical DBA Quality Care Products LLCANDACurrent
68025-046LorzonechlorzoxazoneVertical Pharmaceuticals, Inc.ANDACurrent
68025-046LorzonechlorzoxazoneVertical Pharmaceuticals, Inc.ANDACurrent
68025-046LorzonechlorzoxazoneVertical Pharmaceuticals, Inc.ANDACurrent
68025-047LorzonechlorzoxazoneVertical Pharmaceuticals, Inc.ANDACurrent
68025-047LorzonechlorzoxazoneVertical Pharmaceuticals, Inc.ANDACurrent
68025-047LorzonechlorzoxazoneVertical Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
29967ORIG2010-06-08