FDA.reportPublic FDA data

Application 076999

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLOPIDOGREL BISULFATECLOPIDOGREL BISULFATETABLET;ORALEQ 75MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-7314ClopidogrelClopidogrelTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7314ClopidogrelClopidogrelTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7314ClopidogrelClopidogrelTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7314ClopidogrelClopidogrelTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7314ClopidogrelClopidogrelTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7314ClopidogrelClopidogrelTeva Pharmaceuticals USA, Inc.ANDACurrent
0615-7719ClopidogrelClopidogrelNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
53808-1025ClopidogrelClopidogrelState of Florida DOH Central PharmacyANDACurrent
54458-888ClopidogrelClopidogrelInternational Laboratories, LLCANDACurrent
54458-888ClopidogrelClopidogrelInternational Laboratories, LLCANDACurrent
63187-362ClopidogrelClopidogrelProficient Rx LPANDACurrent
63187-362ClopidogrelClopidogrelProficient Rx LPANDACurrent
63629-4728ClopidogrelClopidogrelBryant Ranch PrepackANDACurrent
63629-4728ClopidogrelClopidogrelBryant Ranch PrepackANDACurrent
66116-494ClopidogrelClopidogrelMedVantx, Inc.ANDACurrent
68071-4138ClopidogrelClopidogrelNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4138ClopidogrelClopidogrelNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4138ClopidogrelClopidogrelNuCare Pharmaceuticals,Inc.ANDACurrent
68645-430ClopidogrelClopidogrelLegacy Pharmaceutical PackagingANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31184ORIG2012-05-18