FDA.reportPublic FDA data

Application 081297

Type
ANDA
Sponsor
BIONPHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BENZONATATEBENZONATATECAPSULE;ORAL100MGNoNo
002BENZONATATEBENZONATATECAPSULE;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-1349BenzonatateBenzonatateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
53002-0411BenzonatateBenzonatateRPK Pharmaceuticals, Inc.ANDACurrent
53002-0411BenzonatateBenzonatateRPK Pharmaceuticals, Inc.ANDACurrent
55700-363BenzonatateBenzonatateLake Erie Medical DBA Quality Care Products LLCANDACurrent
60429-905BenzonatateBenzonatateGolden State Medical Supply, Inc.ANDACurrent
60429-905BenzonatateBenzonatateGolden State Medical Supply, Inc.ANDACurrent
60429-914BenzonatateBenzonatateGolden State Medical Supply, Inc.ANDACurrent
60429-914BenzonatateBenzonatateGolden State Medical Supply, Inc.ANDACurrent
60429-914BenzonatateBenzonatateGolden State Medical Supply, Inc.ANDACurrent
60429-927BenzonatateBenzonatateGolden State Medical Supply, Inc.ANDACurrent
60429-927BenzonatateBenzonatateGolden State Medical Supply, Inc.ANDACurrent
60429-927BenzonatateBenzonatateGolden State Medical Supply, Inc.ANDACurrent
63629-2443BenzonatateBenzonatateBryant Ranch PrepackANDACurrent
63629-2443BenzonatateBenzonatateBryant Ranch PrepackANDACurrent
63629-2444BenzonatateBenzonatateBryant Ranch PrepackANDACurrent
63629-2444BenzonatateBenzonatateBryant Ranch PrepackANDACurrent
63629-2655BenzonatateBenzonatateBryant Ranch PrepackANDACurrent
66116-513BenzonatateBenzonatateMedVantx, Inc.ANDACurrent
67296-1361BenzonatateBenzonatateRedPharm Drug, Inc.ANDACurrent
67296-1361BenzonatateBenzonatateRedPharm Drug, Inc.ANDACurrent
67296-1371BenzonatateBenzonatateRedPharm Drug, Inc.ANDACurrent
67296-1371BenzonatateBenzonatateRedPharm Drug, Inc.ANDACurrent
67296-1576BenzonatateBenzonatateRedPharm Drug, Inc.ANDACurrent
67296-1576BenzonatateBenzonatateRedPharm Drug, Inc.ANDACurrent
67296-1576BenzonatateBenzonatateRedPharm Drug, Inc.ANDACurrent
68071-5105BenzonatateBenzonatateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5105BenzonatateBenzonatateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5156BenzonatateBenzonatateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5156BenzonatateBenzonatateNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7569BenzonatateBenzonatatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7569BenzonatateBenzonatatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-8133BenzonatateBenzonatatePreferred Pharmaceuticals Inc..ANDACurrent
69387-119BenzonatateBenzonatateBanner Life Sciences LLC.ANDACurrent
69387-120BenzonatateBenzonatateBanner Life Sciences LLC.ANDACurrent
69452-143BenzonatateBenzonatateBionpharma Inc.ANDACurrent
69452-144BenzonatateBenzonatateBionpharma Inc.ANDACurrent
70934-943BenzonatateBenzonatateDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-943BenzonatateBenzonatateDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-067BenzonatateBenzonatateProficient Rx LPANDACurrent
71205-067BenzonatateBenzonatateProficient Rx LPANDACurrent
71205-067BenzonatateBenzonatateProficient Rx LPANDACurrent
71205-605BenzonatateBenzonatateProficient Rx LPANDACurrent
71205-605BenzonatateBenzonatateProficient Rx LPANDACurrent
71335-0054BenzonatateBenzonatateBryant Ranch PrepackANDACurrent
71335-1880BenzonatateBenzonatateBryant Ranch PrepackANDACurrent
71335-1927BenzonatateBenzonatateBryant Ranch PrepackANDACurrent