FDA.reportPublic FDA data

Application 078671

Type
ANDA
Sponsor
INVAGEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NABUMETONENABUMETONETABLET;ORAL500MGNoNo
002NABUMETONENABUMETONETABLET;ORAL750MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0440-5843NabumetoneNabumetoneLiberty Pharmaceuticals, Inc.ANDACurrent
0440-5844NabumetoneNabumetoneLiberty Pharmaceuticals, Inc.ANDACurrent
0615-7630NabumetonenabumetoneNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7645NabumetonenabumetoneNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
10544-003NabumetoneNabumetoneBlenheim Pharmacal, Inc.ANDACurrent
10544-271NabumetoneNabumetoneBlenheim Pharmacal, Inc.ANDACurrent
21695-230NabumetoneNabumetoneRebel Distributors Corp.ANDACurrent
21695-231NabumetoneNabumetoneRebel Distributors Corp.ANDACurrent
33261-078NabumetoneNabumetoneAidarex Pharmaceuticals LLCANDACurrent
33358-251NabumetoneNabumetoneRxChange Co.ANDACurrent
33358-252NabumetoneNabumetoneRxChange Co.ANDACurrent
35356-686NabumetoneNabumetoneLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
35356-726NabumetoneNabumetoneLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-726NabumetoneNabumetoneLake Erie Medical DBA Quality Care Products LLCANDACurrent
43063-972NabumetoneNabumetonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-972NabumetoneNabumetonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-972NabumetoneNabumetonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-972NabumetoneNabumetonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-972NabumetoneNabumetonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-972NabumetoneNabumetonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-973NabumetoneNabumetonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-973NabumetoneNabumetonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-973NabumetoneNabumetonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-973NabumetoneNabumetonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-973NabumetoneNabumetonePD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-351NabumetoneNabumetoneMedsource PharmaceuticalsANDACurrent
45865-351NabumetoneNabumetoneMedsource PharmaceuticalsANDACurrent
45865-464NabumetoneNabumetoneMedsource PharmaceuticalsANDACurrent
45865-464NabumetoneNabumetoneMedsource PharmaceuticalsANDACurrent
50090-1531NabumetoneNabumetoneA-S Medication SolutionsANDACurrent
50090-1531NabumetoneNabumetoneA-S Medication SolutionsANDACurrent
50090-1531NabumetoneNabumetoneA-S Medication SolutionsANDACurrent
50090-3433NabumetoneNabumetoneA-S Medication SolutionsANDACurrent
50090-3433NabumetoneNabumetoneA-S Medication SolutionsANDACurrent
50090-5386NabumetoneNabumetoneA-S Medication SolutionsANDACurrent
50436-6046NabumetoneNabumetoneUnit Dose ServicesANDACurrent
50436-6334NabumetoneNabumetoneUnit Dose ServicesANDACurrent
51655-396NabumetoneNabumetoneNorthwind PharmaceuticalsANDACurrent
51655-396NabumetoneNabumetoneNorthwind PharmaceuticalsANDACurrent
52959-650NabumetoneNabumetoneH.J. Harkins Company, Inc.ANDACurrent
52959-656NabumetoneNabumetoneH.J. Harkins Company, Inc.ANDACurrent
53217-260NabumetoneNabumetoneAidarex Pharmaceuticals LLCANDACurrent
60687-630NabumetoneNabumetoneAmerican Health PackagingANDACurrent
60760-015NabumetoneNabumetoneSt.Mary's Medical Park PharmacyANDACurrent
60760-696NabumetoneNabumetoneSt. Mary's Medical Park PharmacyANDACurrent
61919-668NABUMETONENABUMETONEDIRECT RXANDACurrent
61919-668NABUMETONENABUMETONEDirect_RxANDACurrent
61919-668NABUMETONENABUMETONEDirect_RxANDACurrent
61919-698NABUMETONENABUMETONEDirect_RxANDACurrent
61919-698NABUMETONENABUMETONEDirect_RxANDACurrent
63187-378NabumetoneNabumetoneProficient Rx LPANDACurrent
63187-378NabumetoneNabumetoneProficient Rx LPANDACurrent
63187-484NabumetoneNabumetoneProficient Rx LPANDACurrent
63187-484NabumetoneNabumetoneProficient Rx LPANDACurrent
63629-2682NabumetoneNabumetoneBryant Ranch PrepackANDACurrent
63629-2682NabumetoneNabumetoneBryant Ranch PrepackANDACurrent
66267-482NabumetoneNabumetoneNuCare Pharmaceuticals, Inc.ANDACurrent
66267-482NabumetoneNabumetoneNuCare Pharmaceuticals,Inc.ANDACurrent
66267-482NabumetoneNabumetoneNuCare Pharmaceuticals,Inc.ANDACurrent
66267-482NabumetoneNabumetoneNuCare Pharmaceuticals,Inc.ANDACurrent
66267-529NabumetoneNabumetoneNuCare Pharmaceuticals, Inc.ANDACurrent
66267-529NabumetoneNabumetoneNuCare Pharmaceuticals, Inc.ANDACurrent
66336-316NabumetoneNabumetoneDispensing Solutions, Inc.ANDACurrent
68462-358NabumetoneNabumetoneGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-359NabumetoneNabumetoneGlenmark Pharmaceuticals Inc., USAANDACurrent
68788-9908NabumetoneNabumetonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9908NabumetoneNabumetonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9908NabumetoneNabumetonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9909NabumetoneNabumetonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9909NabumetoneNabumetonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9909NabumetoneNabumetonePreferred Pharmaceuticals, Inc.ANDACurrent
69097-965NabumetoneNabumetoneCipla USA Inc.ANDACurrent
69097-965NabumetoneNabumetoneCipla USA Inc.ANDACurrent
69097-965NabumetoneNabumetoneCipla USA Inc.ANDACurrent
69097-966NabumetoneNabumetoneCipla USA Inc.ANDACurrent
69097-966NabumetoneNabumetoneCipla USA Inc.ANDACurrent
69097-966NabumetoneNabumetoneCipla USA Inc.ANDACurrent
70518-0934NabumetoneNabumetoneREMEDYREPACK INC.ANDACurrent
70518-0934NabumetoneNabumetoneREMEDYREPACK INC.ANDACurrent
70518-0934NabumetoneNabumetoneREMEDYREPACK INC.ANDACurrent