FDA.reportPublic FDA data

Application 205101

Type
ANDA
Sponsor
SCIEGEN PHARMS INC

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
10135-647GabapentinGabapentinMarlex Pharmaceuticals IncANDACurrent
10135-647GabapentinGabapentinMarlex Pharmaceuticals IncANDACurrent
10135-648GabapentinGabapentinMarlex Pharmaceuticals IncANDACurrent
10135-648GabapentinGabapentinMarlex Pharmaceuticals IncANDACurrent
17856-0135GabapentinGabapentinAtlantic Biologicals CorpsANDACurrent
43063-756GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-756GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-756GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-756GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-756GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-757GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-757GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-757GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-757GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-776GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.ANDACurrent
43547-389GABAPENTINGABAPENTINSolco Healthcare U.S., LLCANDACurrent
43547-389GABAPENTINGABAPENTINSolco Healthcare U.S., LLCANDACurrent
43547-389GABAPENTINGABAPENTINSolco Healthcare U.S., LLCANDACurrent
43547-390GABAPENTINGABAPENTINSolco Healthcare U.S., LLCANDACurrent
43547-390GABAPENTINGABAPENTINSolco Healthcare U.S., LLCANDACurrent
43547-390GABAPENTINGABAPENTINSolco Healthcare U.S., LLCANDACurrent
50090-4723GABAPENTINGABAPENTINA-S Medication SolutionsANDACurrent
50090-4723GABAPENTINGABAPENTINA-S Medication SolutionsANDACurrent
50090-5045GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-5045GabapentinGabapentinA-S Medication SolutionsANDACurrent
50228-177GabapentinGabapentinScieGen Pharmaceuticals, Inc.ANDACurrent
50228-177GabapentinGabapentinScieGen Pharmaceuticals, Inc.ANDACurrent
50228-177GabapentinGabapentinScieGen Pharmaceuticals, Inc.ANDACurrent
50228-177GabapentinGabapentinScieGen Pharmaceuticals, Inc.ANDACurrent
50228-177GabapentinGabapentinScieGen Pharmaceuticals, Inc.ANDACurrent
50228-178GabapentinGabapentinScieGen Pharmaceuticals, Inc.ANDACurrent
50228-178GabapentinGabapentinScieGen Pharmaceuticals, Inc.ANDACurrent
50228-178GabapentinGabapentinScieGen Pharmaceuticals, Inc.ANDACurrent
50228-178GabapentinGabapentinScieGen Pharmaceuticals, Inc.ANDACurrent
50228-178GabapentinGabapentinScieGen Pharmaceuticals, Inc.ANDACurrent
55700-686GabapentinGabapentinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-686GabapentinGabapentinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-686GabapentinGabapentinLake Erie Medical DBA Quality Care Products LLCANDACurrent
58657-623GABAPENTINGABAPENTINMethod Pharmaceuticals, LLCANDACurrent
58657-623GABAPENTINGABAPENTINMethod Pharmaceuticals, LLCANDACurrent
58657-624GABAPENTINGABAPENTINMethod Pharmaceuticals, LLCANDACurrent
58657-624GABAPENTINGABAPENTINMethod Pharmaceuticals, LLCANDACurrent
60760-517GabapentinGabapentinSt. Mary's Medical Park PharmacyANDACurrent
60760-743GabapentinGabapentinSt. Mary's Medical Park PharmacyANDACurrent
60760-743GabapentinGabapentinSt. Mary's Medical Park PharmacyANDACurrent
63629-8489GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-8489GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-8490GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-8490GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-8491GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-8491GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-8492GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-8492GabapentinGabapentinBryant Ranch PrepackANDACurrent
67296-1745GABAPENTINGABAPENTINRedPharm Drug, Inc.ANDACurrent
68071-2206GabapentinGabapentinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2206GabapentinGabapentinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2214GabapentinGabapentinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2214GabapentinGabapentinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2353GABAPENTINGABAPENTINNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2463GabapentinGabapentinNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7757GabapentinGabapentinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7757GabapentinGabapentinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7757GabapentinGabapentinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7774GabapentinGabapentinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7774GabapentinGabapentinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7774GabapentinGabapentinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7840GabapentinGabapentinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7840GabapentinGabapentinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7840GabapentinGabapentinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7847GabapentinGabapentinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7847GabapentinGabapentinPreferred Pharmaceuticals Inc.ANDACurrent
69367-134GabapentinGabapentinWestminster Pharmaceuticals, LLCANDACurrent
69367-134GabapentinGabapentinWestminster Pharmaceuticals, LLCANDACurrent
69367-134GabapentinGabapentinWestminster Pharmaceuticals, LLCANDACurrent
69367-134GabapentinGabapentinWestminster Pharmaceuticals, LLCANDACurrent
69367-134GabapentinGabapentinWestminster Pharmaceuticals, LLCANDACurrent
69367-134GabapentinGabapentinWestminster Pharmaceuticals, LLCANDACurrent
69367-135GabapentinGabapentinWestminster Pharmaceuticals, LLCANDACurrent
69367-135GabapentinGabapentinWestminster Pharmaceuticals, LLCANDACurrent
69367-135GabapentinGabapentinWestminster Pharmaceuticals, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32630ORIG2016-02-11