FDA.reportPublic FDA data

Application 090007

Type
ANDA
Sponsor
MARKSANS PHARMA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
25000-103GABAPENTINGABAPENTINMARKSANS PHARMA LIMITEDANDACurrent
25000-103GABAPENTINGABAPENTINMARKSANS PHARMA LIMITEDANDACurrent
25000-103GABAPENTINGABAPENTINMARKSANS PHARMA LIMITEDANDACurrent
25000-103GABAPENTINGABAPENTINMARKSANS PHARMA LIMITEDANDACurrent
25000-103GABAPENTINGABAPENTINMARKSANS PHARMA LIMITEDANDACurrent
25000-104GABAPENTINGABAPENTINMARKSANS PHARMA LIMITEDANDACurrent
25000-104GABAPENTINGABAPENTINMARKSANS PHARMA LIMITEDANDACurrent
25000-104GABAPENTINGABAPENTINMARKSANS PHARMA LIMITEDANDACurrent
25000-104GABAPENTINGABAPENTINMARKSANS PHARMA LIMITEDANDACurrent
25000-104GABAPENTINGABAPENTINMARKSANS PHARMA LIMITEDANDACurrent
25000-105GABAPENTINGABAPENTINMARKSANS PHARMA LIMITEDANDACurrent
25000-105GABAPENTINGABAPENTINMARKSANS PHARMA LIMITEDANDACurrent
25000-105GABAPENTINGABAPENTINMARKSANS PHARMA LIMITEDANDACurrent
25000-105GABAPENTINGABAPENTINMARKSANS PHARMA LIMITEDANDACurrent
25000-105GABAPENTINGABAPENTINMARKSANS PHARMA LIMITEDANDACurrent
42495-266GabapentinGABAPENTINMSM RepackagingANDACurrent
42582-114GabapentinGabapentinBi-Coastal Pharma International LLCANDACurrent
42582-115GabapentinGabapentinBi-Coastal Pharma International LLCANDACurrent
42582-116GabapentinGabapentinBi-Coastal Pharma International LLCANDACurrent
43547-265GabapentinGABAPENTINSolco Healthcare U.S., LLCANDACurrent
43547-265GabapentinGABAPENTINSolco Healthcare U.S., LLCANDACurrent
43547-266GabapentinGABAPENTINSolco Healthcare U.S., LLCANDACurrent
43547-266GabapentinGABAPENTINSolco Healthcare U.S., LLCANDACurrent
43547-267GabapentinGABAPENTINSolco Healthcare U.S., LLCANDACurrent
43547-267GabapentinGABAPENTINSolco Healthcare U.S., LLCANDACurrent
49483-605GABAPENTINGABAPENTINTIME CAP LABORATORIES, INCANDACurrent
49483-605GABAPENTINGABAPENTINTIME CAP LABORATORIES, INCANDACurrent
49483-605GABAPENTINGABAPENTINTIME CAP LABORATORIES, INCANDACurrent
49483-605GABAPENTINGABAPENTINTIME CAP LABORATORIES, INCANDACurrent
49483-606GABAPENTINGABAPENTINTIME CAP LABORATORIES, INCANDACurrent
49483-606GABAPENTINGABAPENTINTIME CAP LABORATORIES, INCANDACurrent
49483-606GABAPENTINGABAPENTINTIME CAP LABORATORIES, INCANDACurrent
49483-606GABAPENTINGABAPENTINTIME CAP LABORATORIES, INCANDACurrent
49483-607GABAPENTINGABAPENTINTIME CAP LABORATORIES, INCANDACurrent
49483-607GABAPENTINGABAPENTINTIME CAP LABORATORIES, INCANDACurrent
49483-607GABAPENTINGABAPENTINTIME CAP LABORATORIES, INCANDACurrent
49483-607GABAPENTINGABAPENTINTIME CAP LABORATORIES, INCANDACurrent
50268-348GabapentinGABAPENTINAvPAKANDACurrent
50268-349GabapentinGABAPENTINAvPAKANDACurrent
51655-379GABAPENTINGABAPENTINNorthwind PharmaceuticalsANDACurrent
53002-2423GABAPENTINGABAPENTINRPK Pharmaceuticals, Inc.ANDACurrent
53002-2423GABAPENTINGABAPENTINRPK Pharmaceuticals, Inc.ANDACurrent
55700-386GabapentinGABAPENTINLake Erie Medical DBA Quality Care Products LLCANDACurrent
60760-088GABAPENTINGABAPENTINSt. Mary's Medical Park PharmacyANDACurrent
60760-088GABAPENTINGABAPENTINSt. Mary's Medical Park PharmacyANDACurrent
60760-088GABAPENTINGABAPENTINSt. Mary's Medical Park PharmacyANDACurrent
60760-088GABAPENTINGABAPENTINSt. Mary's Medical Park PharmacyANDACurrent
60760-088GABAPENTINGABAPENTINSt. Mary's Medical Park PharmacyANDACurrent
60760-605GABAPENTINGABAPENTINSt. MaryANDACurrent
60760-605GABAPENTINGABAPENTINSt. MaryANDACurrent
61919-640GABAPENTINGABAPENTINDIRECT RXANDACurrent
61919-640GABAPENTINGABAPENTINDirect_RxANDACurrent
61919-640GABAPENTINGABAPENTINDirect_RxANDACurrent
61919-640GABAPENTINGABAPENTINDirect_RxANDACurrent
61919-640GABAPENTINGABAPENTINDirect_RxANDACurrent
67296-1638GABAPENTINGABAPENTINRedPharm Drug, Inc.ANDACurrent
67296-1638GABAPENTINGABAPENTINRedPharm Drug, Inc.ANDACurrent
67296-1638GABAPENTINGABAPENTINRedPharm Drug, Inc.ANDACurrent
68071-3230GABAPENTINGABAPENTINNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3230GABAPENTINGABAPENTINNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4049GABAPENTINGABAPENTINNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4049GABAPENTINGABAPENTINNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4049GABAPENTINGABAPENTINNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4784GABAPENTINGABAPENTINNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4784GABAPENTINGABAPENTINNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4784GABAPENTINGABAPENTINNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5017GABAPENTINGABAPENTINNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5017GABAPENTINGABAPENTINNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7024GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.ANDACurrent
68788-7024GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.ANDACurrent
68788-7038GABAPENTINGABAPENTINPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7038GABAPENTINGABAPENTINPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7038GABAPENTINGABAPENTINPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7135GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.ANDACurrent
68788-7135GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.ANDACurrent
68788-7135GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.ANDACurrent
68788-7727GABAPENTINGABAPENTINPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7727GABAPENTINGABAPENTINPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7727GABAPENTINGABAPENTINPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7869GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.ANDACurrent