FDA.reportPublic FDA data

Application 075189

Type
ANDA
Sponsor
IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NABUMETONENABUMETONETABLET;ORAL500MGNoNo
002NABUMETONENABUMETONETABLET;ORAL750MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1657NabumetoneNabumetoneImpax GenericsANDACurrent
0115-1657NabumetoneNabumetoneAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1657NabumetoneNabumetoneImpax GenericsANDACurrent
0115-1658NabumetoneNabumetoneImpax GenericsANDACurrent
0115-1658NabumetoneNabumetoneImpax GenericsANDACurrent
0115-1658NabumetoneNabumetoneAmneal Pharmaceuticals of New York LLCANDACurrent
0615-7666NabumetoneNabumetoneNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7667NabumetoneNabumetoneNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
43063-859NabumetoneNabumetonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-859NabumetoneNabumetonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-859NabumetoneNabumetonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-859NabumetoneNabumetonePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-859NabumetoneNabumetonePD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-997NabumetoneNabumetonemedsource pharmaceuticalsANDACurrent
55700-752NabumetoneNabumetoneQuality Care Products, LLCANDACurrent
55700-765NabumetoneNabumetoneQuality Care Products, LLCANDACurrent
55700-765NabumetoneNabumetoneQuality Care Products, LLCANDACurrent
61919-159NABUMETONENABUMETONEDirect RxANDACurrent
61919-159NABUMETONENABUMETONEDIRECT RXANDACurrent
61919-159NABUMETONENABUMETONEDIRECT RXANDACurrent
61919-160NABUMETONENABUMETONEDirect RxANDACurrent
68788-7532NabumetoneNabumetonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7532NabumetoneNabumetonePreferred Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8557ORIG2004-06-09
30789SUPPL2003-04-09
30788SUPPL2003-04-09
42956ORIG2000-05-26
30787ORIG2000-05-26
18392ORIG2000-05-26