FDA.reportPublic FDA data

Application 204989

Type
ANDA
Sponsor
SCIEGEN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GABAPENTINGABAPENTINCAPSULE;ORAL100MGNoNo
002GABAPENTINGABAPENTINCAPSULE;ORAL300MGNoNo
003GABAPENTINGABAPENTINCAPSULE;ORAL400MGNoNo
004RELGAABIGABAPENTINCAPSULE;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10135-644GabapentinGabapentinMarlex Pharmaceuticals IncANDACurrent
10135-644GabapentinGabapentinMarlex Pharmaceuticals IncANDACurrent
10135-645GabapentinGabapentinMarlex Pharmaceuticals IncANDACurrent
10135-645GabapentinGabapentinMarlex Pharmaceuticals IncANDACurrent
10135-646GabapentinGabapentinMarlex Pharmaceuticals IncANDACurrent
10135-646GabapentinGabapentinMarlex Pharmaceuticals IncANDACurrent
43063-758GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-758GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-758GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-758GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-759GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-759GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-759GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-759GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-760GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-760GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-760GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-760GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-760GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-775GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.ANDACurrent
43547-383GABAPENTINGABAPENTINSolco Healthcare U.S., LLCANDACurrent
43547-383GABAPENTINGABAPENTINSolco Healthcare U.S., LLCANDACurrent
43547-383GABAPENTINGABAPENTINSolco Healthcare U.S., LLCANDACurrent
43547-384GABAPENTINGABAPENTINSolco Healthcare U.S., LLCANDACurrent
43547-384GABAPENTINGABAPENTINSolco Healthcare U.S., LLCANDACurrent
43547-384GABAPENTINGABAPENTINSolco Healthcare U.S., LLCANDACurrent
43547-385GABAPENTINGABAPENTINSolco Healthcare U.S., LLCANDACurrent
43547-385GABAPENTINGABAPENTINSolco Healthcare U.S., LLCANDACurrent
43547-385GABAPENTINGABAPENTINSolco Healthcare U.S., LLCANDACurrent
50228-179GabapentinGabapentinScieGen Pharmaceuticals, Inc.ANDACurrent
50228-179GabapentinGabapentinScieGen Pharmaceuticals, Inc.ANDACurrent
50228-179GabapentinGabapentinScieGen Pharmaceuticals, Inc.ANDACurrent
50228-179GabapentinGabapentinScieGen Pharmaceuticals, Inc.ANDACurrent
50228-179GabapentinGabapentinScieGen Pharmaceuticals, Inc.ANDACurrent
50228-179GabapentinGabapentinScieGen Pharmaceuticals, Inc.ANDACurrent
50228-180GabapentinGabapentinScieGen Pharmaceuticals, Inc.ANDACurrent
50228-180GabapentinGabapentinScieGen Pharmaceuticals, Inc.ANDACurrent
50228-180GabapentinGabapentinScieGen Pharmaceuticals, Inc.ANDACurrent
50228-180GabapentinGabapentinScieGen Pharmaceuticals, Inc.ANDACurrent
50228-180GabapentinGabapentinScieGen Pharmaceuticals, Inc.ANDACurrent
50228-180GabapentinGabapentinScieGen Pharmaceuticals, Inc.ANDACurrent
50228-181GabapentinGabapentinScieGen Pharmaceuticals, Inc.ANDACurrent
50228-181GabapentinGabapentinScieGen Pharmaceuticals, Inc.ANDACurrent
50228-181GabapentinGabapentinScieGen Pharmaceuticals, Inc.ANDACurrent
50228-181GabapentinGabapentinScieGen Pharmaceuticals, Inc.ANDACurrent
50228-181GabapentinGabapentinScieGen Pharmaceuticals, Inc.ANDACurrent
50228-181GabapentinGabapentinScieGen Pharmaceuticals, Inc.ANDACurrent
50436-0383GABAPENTINGABAPENTINUnit Dose ServicesANDACurrent
50436-0383GABAPENTINGABAPENTINUnit Dose ServicesANDACurrent
50436-0383GABAPENTINGABAPENTINUnit Dose ServicesANDACurrent
50436-0384GABAPENTINGABAPENTINUnit Dose ServicesANDACurrent
50436-0384GABAPENTINGABAPENTINUnit Dose ServicesANDACurrent
50436-0384GABAPENTINGABAPENTINUnit Dose ServicesANDACurrent
51407-047GabapentinGabapentinGolden State Medical SupplyANDACurrent
51407-047GabapentinGabapentinGolden State Medical Supply, Inc.ANDACurrent
51407-047GabapentinGabapentinGolden State Medical Supply, Inc.ANDACurrent
51407-047GabapentinGabapentinGolden State Medical SupplyANDACurrent
51407-047GabapentinGabapentinGolden State Medical Supply, Inc.ANDACurrent
51407-047GabapentinGabapentinGolden State Medical Supply Inc.ANDACurrent
51407-048GabapentinGabapentinGolden State Medical Supply Inc.ANDACurrent
51407-048GabapentinGabapentinGolden State Medical SupplyANDACurrent
51407-048GabapentinGabapentinGolden State Medical SupplyANDACurrent
51407-048GabapentinGabapentinGolden State Medical Supply, Inc.ANDACurrent
51407-048GabapentinGabapentinGolden State Medical Supply, Inc.ANDACurrent
51407-048GabapentinGabapentinGolden State Medical Supply, Inc.ANDACurrent
51407-049GabapentinGabapentinGolden State Medical Supply, Inc.ANDACurrent
51407-049GabapentinGabapentinGolden State Medical Supply, Inc.ANDACurrent
51407-049GabapentinGabapentinGolden State Medical Supply, Inc.ANDACurrent
51407-049GabapentinGabapentinGolden State Medical SupplyANDACurrent
51407-049GabapentinGabapentinGolden State Medical Supply Inc.ANDACurrent
51407-049GabapentinGabapentinGolden State Medical SupplyANDACurrent
53002-5472GabapentinGabapentinRPK Pharmaceuticals, Inc.ANDACurrent
53002-6423GabapentinGabapentinRPK Pharmaceuticals, Inc.ANDACurrent
55700-763GabapentinGabapentinQuality Care Products, LLCANDACurrent
55700-949GabapentinGabapentinQuality Care Products, LLCANDACurrent
55700-949GabapentinGabapentinQuality Care Products, LLCANDACurrent
55700-949GabapentinGabapentinQuality Care Products, LLCANDACurrent
55700-950GabapentinGabapentinQuality Care Products, LLCANDACurrent
55700-950GabapentinGabapentinQuality Care Products, LLCANDACurrent
55700-950GabapentinGabapentinQuality Care Products, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10412ORIG2016-02-22