FDA.reportPublic FDA data

Application 077836

Type
ANDA
Sponsor
INVAGEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GEMFIBROZILGEMFIBROZILTABLET;ORAL600MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9130GemfibrozilGemfibrozilWest-ward Pharmaceutical CorpANDACurrent
0179-0221GemfibrozilGemfibrozilKAISER FOUNDATION HOSPITALSANDACurrent
21695-732GemfibrozilGemfibrozilRebel Distributors CorpANDACurrent
31722-225GemfibrozilGemfibrozilCamber PharmaceuticalsANDACurrent
43063-745GemfibrozilGemfibrozilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-745GemfibrozilGemfibrozilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-745GemfibrozilGemfibrozilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-745GemfibrozilGemfibrozilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-745GemfibrozilGemfibrozilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-745GemfibrozilGemfibrozilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-090GemfibrozilGemfibrozilAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-0458GemfibrozilGemfibrozilA-S Medication SolutionsANDACurrent
50090-2902GemfibrozilGemfibrozilA-S Medication SolutionsANDACurrent
50090-2902GemfibrozilGemfibrozilA-S Medication SolutionsANDACurrent
50090-2902GemfibrozilGemfibrozilA-S Medication SolutionsANDACurrent
50090-2902GemfibrozilGemfibrozilA-S Medication SolutionsANDACurrent
50268-350GemfibrozilGemfibrozilAvPAKANDACurrent
50268-350GemfibrozilGemfibrozilAvPAKANDACurrent
51138-588GemfibrozilGemfibrozilMed-Health Pharma, LLCANDACurrent
51655-142GemfibrozilGemfibrozilNorthwind Pharmaceuticals, LLCANDACurrent
51655-143GemfibrozilGemfibrozilNorthwind Pharmaceuticals, LLCANDACurrent
51655-143GemfibrozilGemfibrozilNorthwind Pharmaceuticals, LLCANDACurrent
53002-1068GemfibrozilGemfibrozilRPK Pharmaceuticals, Inc.ANDACurrent
53002-1068GemfibrozilGemfibrozilRPK Pharmaceuticals, Inc.ANDACurrent
53217-251GemfibrozilGemfibrozilAidarex Pharmaceuticals LLCANDACurrent
53808-0673GemfibrozilGemfibrozilState of Florida DOH Central PharmacyANDACurrent
55700-493GemfibrozilGemfibrozilLake Erie Medical DBA QuaANDACurrent
55700-493GemfibrozilGemfibrozilLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-493GemfibrozilGemfibrozilLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-493GemfibrozilGemfibrozilLake Erie Medical DBA Quality Care Products LLCANDACurrent
60687-224GemfibrozilGemfibrozilAmerican Health PackagingANDACurrent
60687-224GemfibrozilGemfibrozilAmerican Health PackagingANDACurrent
60687-224GemfibrozilGemfibrozilAmerican Health PackagingANDACurrent
60687-224GemfibrozilGemfibrozilAmerican Health PackagingANDACurrent
60687-224GemfibrozilGemfibrozilAmerican Health PackagingANDACurrent
61919-967GEMFIBROZILGEMFIBROZILdirect rxANDACurrent
61919-967GEMFIBROZILGEMFIBROZILDirect_RxANDACurrent
61919-967GEMFIBROZILGEMFIBROZILDirect_RxANDACurrent
61919-967GEMFIBROZILGEMFIBROZILDirect_RxANDACurrent
61919-967GEMFIBROZILGEMFIBROZILDirect_RxANDACurrent
61919-968GEMFIBROZILGEMFIBROZILDirectRXANDACurrent
61919-968GEMFIBROZILGEMFIBROZILDirectRXANDACurrent
63187-146GemfibrozilGemfibrozilProficient Rx LPANDACurrent
63187-146GemfibrozilGemfibrozilProficient Rx LPANDACurrent
63187-772GemfibrozilGemfibrozilProficient Rx LPANDACurrent
63187-772GemfibrozilGemfibrozilProficient Rx LPANDACurrent
63187-772GemfibrozilGemfibrozilProficient Rx LPANDACurrent
63187-772GemfibrozilGemfibrozilProficient Rx LPANDACurrent
66267-436GemfibrozilGemfibrozilNuCare Pharmaceuticals, Inc.ANDACurrent
66267-436GemfibrozilGemfibrozilNuCare Pharmaceuticals, Inc.ANDACurrent
66336-367GemfibrozilGemfibrozilDispensing Solutions, Inc.ANDACurrent
67046-231GemfibrozilGemfibrozilContract Pharmacy Services-PAANDACurrent
67046-233GemfibrozilGemfibrozilContract Pharmacy Services-PAANDACurrent
68071-1733GemfibrozilGemfibrozilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1733GemfibrozilGemfibrozilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4011GEMFIBROZILGEMFIBROZILNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4011GEMFIBROZILGEMFIBROZILNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4053GEMFIBROZILGEMFIBROZILNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4053GEMFIBROZILGEMFIBROZILNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4053GEMFIBROZILGEMFIBROZILNuCare Pharmaceuticals,Inc.ANDACurrent
68151-2893GemfibrozilGemfibrozilCarilion Materials ManagementANDACurrent
68788-6447GemfibrozilGemfibrozilPreferred Pharmaceuticals Inc.ANDACurrent
68788-6447GemfibrozilGemfibrozilPreferred Pharmaceuticals Inc.ANDACurrent
68788-6447GemfibrozilGemfibrozilPreferred Pharmaceuticals Inc.ANDACurrent
68788-6447GemfibrozilGemfibrozilPreferred Pharmaceuticals Inc.ANDACurrent
68788-6447GemfibrozilGemfibrozilPreferred Pharmaceuticals Inc.ANDACurrent
68788-7011GEMFIBROZILGEMFIBROZILPreferred Pharmaceuticals Inc.ANDACurrent
68788-9149GemfibrozilGemfibrozilPreferred Pharmaceuticals, IncANDACurrent
69097-821GemfibrozilGemfibrozilCipla USA Inc.ANDACurrent
69097-821GemfibrozilGemfibrozilCipla USA Inc.ANDACurrent
69097-821GemfibrozilGemfibrozilCipla USA Inc.ANDACurrent
69097-821GemfibrozilGemfibrozilCipla USA Inc.ANDACurrent
70518-1301GemfibrozilGemfibrozilREMEDYREPACK INC.ANDACurrent
70518-1301GemfibrozilGemfibrozilREMEDYREPACK INC.ANDACurrent
70518-1563GemfibrozilGemfibrozilREMEDYREPACK INC.ANDACurrent
70518-1563GemfibrozilGemfibrozilREMEDYREPACK INC.ANDACurrent
70518-1563GemfibrozilGemfibrozilREMEDYREPACK INC.ANDACurrent
70518-1563GemfibrozilGemfibrozilREMEDYREPACK INC.ANDACurrent
70518-1563GemfibrozilGemfibrozilREMEDYREPACK INC.ANDACurrent
70518-1563GemfibrozilGemfibrozilREMEDYREPACK INC.ANDACurrent