FDA.reportPublic FDA data

Application 040682

Type
ANDA
Sponsor
ORIT LABS LLC

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
10135-632BenzonatateBenzonatateMarlex Pharmaceuticals IncANDACurrent
12634-826BenzonatateBenzonatateApotheca Inc.ANDACurrent
35356-863BenzonatateBenzonatateLake Erie Medical DBA Quality Care Products LLCANDACurrent
42254-078BenzonatateBenzonatateRebel Distributors CorpANDACurrent
42291-164BenzonatateBenzonatateAvKAREANDACurrent
42291-164BenzonatateBenzonatateAvKARE, Inc.ANDACurrent
42291-165BenzonatateBenzonatateAvKARE, Inc.ANDACurrent
42708-015BenzonatateBenzonatateQPharma IncANDACurrent
43063-979BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-979BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-979BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-979BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-979BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-979BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-979BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-979BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-979BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-979BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-980BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-980BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-980BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-980BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-980BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-980BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-980BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-980BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-980BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-980BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-981BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-981BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-981BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-981BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-981BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-981BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-981BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-981BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-981BENZONATATEBENZONATATEPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-0532BenzonatateBenzonatateA-S Medication SolutionsANDACurrent
50090-0533BenzonatateBenzonatateA-S Medication SolutionsANDACurrent
50090-0872BenzonatateBenzonatateA-S Medication SolutionsANDACurrent
51655-772BENZONATATEBENZONATATENorthwind Pharmaceuticals, LLCANDACurrent
51655-773BENZONATATEBENZONATATENorthwind PharmaceuticalsANDACurrent
55700-922BENZONATATEBENZONATATEQuality Care Products, LLCANDACurrent
55700-922BENZONATATEBENZONATATEQuality Care Products, LLCANDACurrent
55700-923BENZONATATEBENZONATATEQuality Care Products, LLCANDACurrent
55700-923BENZONATATEBENZONATATEQuality Care Products, LLCANDACurrent
61919-272BenzonatateBenzonatateDirect RXANDACurrent
61919-325BENZONATATEBENZONATATEDirectRXANDACurrent
62135-440BenzonatateBenzonatateChartwell RX, LLCANDACurrent
62135-441BenzonatateBenzonatateChartwell RX, LLCANDACurrent
62332-426BENZONATATEBENZONATATEAlembic Pharmaceuticals Inc.ANDACurrent
62332-426BENZONATATEBENZONATATEAlembic Pharmaceuticals Inc.ANDACurrent
62332-426BENZONATATEBENZONATATEAlembic Pharmaceuticals Inc.ANDACurrent
62332-427BENZONATATEBENZONATATEAlembic Pharmaceuticals Inc.ANDACurrent
62332-427BENZONATATEBENZONATATEAlembic Pharmaceuticals Inc.ANDACurrent
62332-427BENZONATATEBENZONATATEAlembic Pharmaceuticals Inc.ANDACurrent
63187-076BenzonatateBenzonatateProficient Rx LPANDACurrent
63187-076BenzonatateBenzonatateProficient Rx LPANDACurrent
63187-076BenzonatateBenzonatateProficient Rx LPANDACurrent
63629-6690BenzonatateBenzonatateBryant Ranch PrepackANDACurrent
63629-6690BenzonatateBenzonatateBryant Ranch PrepackANDACurrent
64205-536BenzonatateBenzonatateReadyMedsANDACurrent
65162-536BenzonatateBenzonatateAmneal Pharmaceuticals LLCANDACurrent
65162-536BenzonatateBenzonatateAmneal Pharmaceuticals LLCANDACurrent
65162-536BenzonatateBenzonatateAmneal Pharmaceuticals LLCANDACurrent
65162-536BenzonatateBenzonatateAmneal Pharmaceuticals LLCANDACurrent
65162-537BenzonatateBenzonatateAmneal Pharmaceuticals LLCANDACurrent
65162-537BenzonatateBenzonatateAmneal Pharmaceuticals LLCANDACurrent
65162-537BenzonatateBenzonatateAmneal Pharmaceuticals LLCANDACurrent
65162-537BenzonatateBenzonatateAmneal Pharmaceuticals LLCANDACurrent
66116-487BenzonatateBenzonatateMedVantx, Inc.ANDACurrent
67296-0567BenzonatateBenzonatateRedPharm Drug Inc.ANDACurrent
67296-1768BENZONATATEBENZONATATERedPharm Drug, Inc.ANDACurrent
67296-1768BENZONATATEBENZONATATERedPharm Drug, Inc.ANDACurrent
68151-2697BenzonatateBenzonatateCarilion Materials ManagementANDACurrent
68788-8127BENZONATATEBENZONATATEPreferred Pharmaceuticals Inc.ANDACurrent
68788-9827BenzonatateBenzonatatePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0008BenzonatateBenzonatateREMEDYREPACK INC.ANDACurrent
70518-0837BenzonatateBenzonatateREMEDYREPACK INC.ANDACurrent
70518-0837BenzonatateBenzonatateREMEDYREPACK INC.ANDACurrent