FDA.report

Application 040597

Type
ANDA
Sponsor
ZYDUS PHARMS USA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001BENZONATATEBENZONATATECAPSULE;ORAL100MGNoNo
002BENZONATATEBENZONATATECAPSULE;ORAL200MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7678BenzonatateBenzonatateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-6564BenzonatateBenzonatateMajor Pharmaceuticals, Inc.ANDACurrent
0904-6564BenzonatateBenzonatateMajor Pharmaceuticals, Inc.ANDACurrent
0904-6564BenzonatateBenzonatateMajor Pharmaceuticals, Inc.ANDACurrent
0904-6564BenzonatateBenzonatateMajor Pharmaceuticals, Inc.ANDACurrent
55154-7995BenzonatateBenzonatateCardinal HealthANDACurrent
55154-7995BenzonatateBenzonatateCardinal Health 107, LLCANDACurrent
55154-7995BenzonatateBenzonatateCardinal HealthANDACurrent
60760-247BenzonatateBenzonatateSt. Mary's Medical Park PharmacyANDACurrent
61919-400BENZONATATEBENZONATATEDIRECT RXANDACurrent
61919-400BENZONATATEBENZONATATEDIRECT RXANDACurrent
63187-799BenzonatateBenzonatateProficient Rx LPANDACurrent
63187-799BenzonatateBenzonatateProficient Rx LPANDACurrent
65841-614BenzonatateBenzonatateCadila Healthcare LimitedANDACurrent
65841-614BenzonatateBenzonatateCadila Healthcare LimitedANDACurrent
65841-614BenzonatateBenzonatateCadila Healthcare LimitedANDACurrent
65841-614BenzonatateBenzonatateZydus Lifesciences LimitedANDACurrent
65841-614BenzonatateBenzonatateCadila Healthcare LimitedANDACurrent
65841-615BenzonatateBenzonatateCadila Healthcare LimitedANDACurrent
65841-615BenzonatateBenzonatateCadila Healthcare LimitedANDACurrent
65841-615BenzonatateBenzonatateCadila Healthcare LimitedANDACurrent
65841-843BenzonatateBenzonatateCadila Healthcare LimitedANDACurrent
65841-843BenzonatateBenzonatateZydus Lifesciences LimitedANDACurrent
66267-033BenzonatateBenzonatateNuCare Pharmaceuticals, Inc.ANDACurrent
66267-033BenzonatateBenzonatateNuCare Pharmaceuticals, Inc.ANDACurrent
66267-765BenzonatateBenzonatateNuCare Pharmaceuticals, Inc.ANDACurrent
66267-765BenzonatateBenzonatateNuCare Pharmaceuticals, Inc.ANDACurrent
66267-877BenzonatateBenzonatateNuCare Pharmaceuticals,Inc.ANDACurrent
66267-877BenzonatateBenzonatateNuCare Pharmaceuticals,Inc.ANDACurrent
67296-1549BenzonatateBenzonatateRedPharm Drug, Inc.ANDACurrent
67296-1549BenzonatateBenzonatateRedPharm Drug, Inc.ANDACurrent
67296-1549BenzonatateBenzonatateRedPharm Drug, Inc.ANDACurrent
68071-4105BenzonatateBenzonatateNuCare Pharmaceuticals,Inc.ANDACurrent
68084-214BenzonatateBenzonatateAmerican Health PackagingANDACurrent
68084-214BenzonatateBenzonatateAmerican Health PackagingANDACurrent
68382-091BenzonatateBenzonatateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-091BenzonatateBenzonatateZydus Pharmaceuticals USA Inc.ANDACurrent
68382-247BenzonatateBenzonatateZydus Pharmaceuticals USA Inc.ANDACurrent
68382-247BenzonatateBenzonatateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-247BenzonatateBenzonatateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-247BenzonatateBenzonatateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-247BenzonatateBenzonatateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-248BenzonatateBenzonatateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-248BenzonatateBenzonatateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-248BenzonatateBenzonatateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68788-6357BenzonatateBenzonatatePreferred Pharmaceuticals Inc.ANDACurrent
68788-6357BenzonatateBenzonatatePreferred Pharmaceuticals Inc.ANDACurrent
70934-058BenzonatateBenzonatateDenton Pharma, Inc.ANDACurrent
70934-058BenzonatateBenzonatateDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-058BenzonatateBenzonatateDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-058BenzonatateBenzonatateDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0091BenzonatateBenzonatateBryant Ranch PrepackANDACurrent