FDA.reportPublic FDA data

Application 091083

Type
ANDA
Sponsor
WATSON LABS

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
0591-3670NabumetoneNabumetoneActavis Pharma, Inc.ANDACurrent
0591-3670NabumetoneNabumetoneActavis Pharma, Inc.ANDACurrent
0591-3670NabumetoneNabumetoneActavis Pharma, Inc.ANDACurrent
0591-3670NabumetoneNabumetoneActavis Pharma, Inc.ANDACurrent
0591-3670NabumetoneNabumetoneActavis Pharma, Inc.ANDACurrent
0591-3670NabumetoneNabumetoneActavis Pharma, Inc.ANDACurrent
0591-3670NabumetoneNabumetoneActavis Pharma, Inc.ANDACurrent
0591-3671NabumetoneNabumetoneActavis Pharma, Inc.ANDACurrent
0591-3671NabumetoneNabumetoneActavis Pharma, Inc.ANDACurrent
0591-3671NabumetoneNabumetoneActavis Pharma, Inc.ANDACurrent
0591-3671NabumetoneNabumetoneActavis Pharma, Inc.ANDACurrent
0591-3671NabumetoneNabumetoneActavis Pharma, Inc.ANDACurrent
0591-3671NabumetoneNabumetoneActavis Pharma, Inc.ANDACurrent
0591-3671NabumetoneNabumetoneActavis Pharma, Inc.ANDACurrent
10544-120NabumetoneNabumetoneBlenheim Pharmacal, Inc.ANDACurrent
33261-077NabumetoneNabumetoneAidarex Pharmaceuticals LLCANDACurrent
35356-687NabumetoneNabumetoneLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
50090-0747NabumetoneNabumetoneA-S Medication SolutionsANDACurrent
50090-0747NabumetoneNabumetoneA-S Medication SolutionsANDACurrent
50090-0800NabumetoneNabumetoneA-S Medication SolutionsANDACurrent
50090-0800NabumetoneNabumetoneA-S Medication SolutionsANDACurrent
50090-0800NabumetoneNabumetoneA-S Medication SolutionsANDACurrent
51655-600NabumetoneNabumetoneNorthwind Pharmaceuticals, LLCANDACurrent
60687-374NabumetoneNabumetoneAmerican Health PackagingANDACurrent
60687-374NabumetoneNabumetoneAmerican Health PackagingANDACurrent
60687-374NabumetoneNabumetoneAmerican Health PackagingANDACurrent
60760-386NabumetoneNabumetoneSt. Mary's Medical Park PharmacyANDACurrent
60760-386NabumetoneNabumetoneSt. Mary's Medical Park PharmacyANDACurrent
60760-386NabumetoneNabumetoneSt. Mary's Medical Park PharmacyANDACurrent
60760-387NabumetoneNabumetoneSt. Mary's Medical Park PharmacyANDACurrent
60760-387NabumetoneNabumetoneSt. Mary's Medical Park PharmacyANDACurrent
61919-626NABUMETONENABUMETONEDIRECT RXANDACurrent
61919-626NABUMETONENABUMETONEDIRECT RXANDACurrent
63187-307NabumetoneNabumetoneProficient Rx LPANDACurrent
63187-307NabumetoneNabumetoneProficient Rx LPANDACurrent
63629-7699NabumetoneNabumetoneBryant Ranch PrepackANDACurrent
63629-7699NabumetoneNabumetoneBryant Ranch PrepackANDACurrent
63629-7699NabumetoneNabumetoneBryant Ranch PrepackANDACurrent
63629-7699NabumetoneNabumetoneBryant Ranch PrepackANDACurrent
68071-4844NabumetoneNabumetoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4844NabumetoneNabumetoneNuCare Pharmaceuticals,Inc.ANDACurrent
68151-0574NabumetoneNabumetoneCarilion Materials ManagementANDACurrent
68788-7220NabumetoneNabumetonePreferred Pharmaceuticals Inc.ANDACurrent
68788-7220NabumetoneNabumetonePreferred Pharmaceuticals Inc.ANDACurrent
68788-7220NabumetoneNabumetonePreferred Pharmaceuticals Inc.ANDACurrent
70934-432NabumetoneNabumetoneDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-432NabumetoneNabumetoneDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-432NabumetoneNabumetoneDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-030NabumetoneNabumetoneProficient Rx LPANDACurrent
71205-030NabumetoneNabumetoneProficient Rx LPANDACurrent
71205-030NabumetoneNabumetoneProficient Rx LPANDACurrent
71205-030NabumetoneNabumetoneProficient Rx LPANDACurrent
71335-1234NabumetoneNabumetoneBryant Ranch PrepackANDACurrent
71335-1234NabumetoneNabumetoneBryant Ranch PrepackANDACurrent
71335-1234NabumetoneNabumetoneBryant Ranch PrepackANDACurrent
71335-1234NabumetoneNabumetoneBryant Ranch PrepackANDACurrent
71335-1272NabumetoneNabumetoneBryant Ranch PrepackANDACurrent
71335-1272NabumetoneNabumetoneBryant Ranch PrepackANDACurrent
71335-1272NabumetoneNabumetoneBryant Ranch PrepackANDACurrent