FDA.reportPublic FDA data

Application 202764

Type
ANDA
Sponsor
INVAGEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GABAPENTINGABAPENTINTABLET;ORAL600MGNoNo
002GABAPENTINGABAPENTINTABLET;ORAL800MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0440-5562GABAPENTINgabapentinLiberty Pharmaceuticals, Inc.ANDACurrent
0440-5563GABAPENTINgabapentinLiberty Pharmaceuticals, Inc.ANDACurrent
31722-405GabapentinGabapentinCamber Pharmaceuticals, Inc.ANDACurrent
31722-406GabapentinGabapentinCamber Pharmaceuticals, Inc.ANDACurrent
33358-154GabapentinGabapentinRxChange Co.ANDACurrent
43353-190GABAPENTINgabapentinAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-190GABAPENTINgabapentinAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-190GABAPENTINgabapentinAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-190GABAPENTINgabapentinAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-872GABAPENTINgabapentinAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-872GABAPENTINgabapentinAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-872GABAPENTINgabapentinAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-872GABAPENTINgabapentinAphena Pharma Solutions - Tennessee, LLCANDACurrent
50268-351GABAPENTINgabapentinAvPAKANDACurrent
50268-351GABAPENTINgabapentinAvPAKANDACurrent
50268-351GABAPENTINgabapentinAvPAKANDACurrent
50268-351GABAPENTINgabapentinAvPAKANDACurrent
50268-352GABAPENTINgabapentinAvPAKANDACurrent
50268-352GABAPENTINgabapentinAvPAKANDACurrent
50268-352GABAPENTINgabapentinAvPAKANDACurrent
52125-816GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
53217-243GabapentinGabapentinAidarex Pharmaceuticals LLCANDACurrent
61919-563GABAPENTINGABAPENTINDIRECT RXANDACurrent
61919-843GABAPENTINGABAPENTINDirectRXANDACurrent
61919-843GABAPENTINGABAPENTINDirectRXANDACurrent
63187-149GabapentinGabapentinProficient Rx LPANDACurrent
63187-149GabapentinGabapentinProficient Rx LPANDACurrent
63187-149GabapentinGabapentinProficient Rx LPANDACurrent
63187-231GabapentinGabapentinProficient Rx LPANDACurrent
63187-231GabapentinGabapentinProficient Rx LPANDACurrent
63187-231GabapentinGabapentinProficient Rx LPANDACurrent
63187-785GabapentinGabapentinProficient Rx LPANDACurrent
63187-785GabapentinGabapentinProficient Rx LPANDACurrent
67046-234GabapentinGabapentinContract Pharmacy Services-PAANDACurrent
67046-238GabapentinGabapentinContract Pharmacy Services-PAANDACurrent
68788-6336GabapentinGabapentinPreferred Pharmaceuticals Inc.ANDACurrent
68788-6336GabapentinGabapentinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7049GabapentinGabapentinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7049GabapentinGabapentinPreferred Pharmaceuticals Inc.ANDACurrent
68788-9299GabapentinGabapentinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9486GabapentinGabapentinPreferred Pharmaceuticals, Inc.ANDACurrent
69097-811GabapentinGabapentinCipla USA Inc.ANDACurrent
69097-811GabapentinGabapentinCipla USA Inc.ANDACurrent
69097-811GabapentinGabapentinCipla USA Inc.ANDACurrent
69097-812GabapentinGabapentinCipla USA Inc.ANDACurrent
69097-812GabapentinGabapentinCipla USA Inc.ANDACurrent
69097-812GabapentinGabapentinCipla USA Inc.ANDACurrent
70518-0483GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-0483GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-0483GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-0483GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-0781GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-0781GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
76282-405GABAPENTINgabapentinExelan Pharmaceuticals Inc.ANDACurrent
76282-405GABAPENTINgabapentinExelan Pharmaceuticals Inc.ANDACurrent
76282-405GABAPENTINgabapentinExelan Pharmaceuticals Inc.ANDACurrent
76282-406GABAPENTINgabapentinExelan Pharmaceuticals Inc.ANDACurrent
76282-406GABAPENTINgabapentinExelan Pharmaceuticals Inc.ANDACurrent
76282-406GABAPENTINgabapentinExelan Pharmaceuticals Inc.ANDACurrent