FDA.reportPublic FDA data

Application 078428

Type
ANDA
Sponsor
AMNEAL PHARMS NY

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
0440-7559GabapentinGabapentinLiberty Pharmaceuticals, Inc.ANDACurrent
0615-8340GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8340GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8340GabapentinGabapentinNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8341GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8341GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8341GabapentinGabapentinNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8342GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8342GabapentinGabapentinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8342GabapentinGabapentinNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
10544-186GabapentinGabapentinBlenheim Pharmacal, Inc.ANDACurrent
33261-048GabapentinGabapentinAidarex Pharmaceuticals LLCANDACurrent
33261-049GabapentinGabapentinAidarex Pharmaceuticals LLCANDACurrent
33261-050GabapentinGabapentinAidarex Pharmaceuticals LLCANDACurrent
33358-153GabapentinGabapentinRxChange Co.ANDACurrent
35356-708GabapentinGabapentinLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
35356-708GabapentinGabapentinLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
35356-708GabapentinGabapentinLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
42254-103GabapentinGabapentinRebel Distributors CorpANDACurrent
42254-112GabapentinGabapentinRebel Distributors CorpANDACurrent
42291-300GabapentinGabapentinAvKARE, Inc.ANDACurrent
42291-301GabapentinGabapentinAvKARE, Inc.ANDACurrent
42291-301GabapentinGabapentinAvKARE, Inc.ANDACurrent
42291-301GabapentinGabapentinAvKAREANDACurrent
45865-347GabapentinGabapentinMedsource PharmaceuticalsANDACurrent
50090-3353GabapentinGabapentinA-S Medication SolutionsANDACurrent
50436-7284GabapentinGabapentinUnit Dose ServicesANDACurrent
53746-101GabapentinGabapentinAmneal Pharmaceuticals of New York LLCANDACurrent
53746-101GabapentinGabapentinAmneal Pharmaceuticals of New York LLCANDACurrent
53746-101GabapentinGabapentinAmneal Pharmaceuticals of New York LLCANDACurrent
53746-101GabapentinGabapentinAmneal Pharmaceuticals of New York LLCANDACurrent
53746-101GabapentinGabapentinAmneal Pharmaceuticals of New York LLCANDACurrent
53746-102GabapentinGabapentinAmneal Pharmaceuticals of New York LLCANDACurrent
53746-102GabapentinGabapentinAmneal Pharmaceuticals of New York LLCANDACurrent
53746-102GabapentinGabapentinAmneal Pharmaceuticals of New York LLCANDACurrent
53746-102GabapentinGabapentinAmneal Pharmaceuticals of New York LLCANDACurrent
53746-102GabapentinGabapentinAmneal Pharmaceuticals of New York LLCANDACurrent
53746-103GabapentinGabapentinAmneal Pharmaceuticals of New York LLCANDACurrent
53746-103GabapentinGabapentinAmneal Pharmaceuticals of New York LLCANDACurrent
53746-103GabapentinGabapentinAmneal Pharmaceuticals of New York LLCANDACurrent
53746-103GabapentinGabapentinAmneal Pharmaceuticals of New York LLCANDACurrent
53746-103GabapentinGabapentinAmneal Pharmaceuticals of New York LLCANDACurrent
55154-6845GabapentinGabapentinCardinal HealthANDACurrent
55154-6845GabapentinGabapentinCardinal HealthANDACurrent
55154-6845GabapentinGabapentinCardinal HealthANDACurrent
55154-6845GabapentinGabapentinCardinal HealthANDACurrent
55154-6846GabapentinGabapentinCardinal HealthANDACurrent
55154-6846GabapentinGabapentinCardinal HealthANDACurrent
55154-6846GabapentinGabapentinCardinal HealthANDACurrent
55154-6846GabapentinGabapentinCardinal HealthANDACurrent
55154-8139GabapentinGabapentinCardinal HealthANDACurrent
55154-8139GabapentinGabapentinCardinal HealthANDACurrent
55154-8139GabapentinGabapentinCardinal HealthANDACurrent
55700-276GabapentinGabapentinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-277GabapentinGabapentinLake Erie Medical DBA Quality Care Products LLCANDACurrent
63629-7306GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7306GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7306GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7306GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7962GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-7962GabapentinGabapentinBryant Ranch PrepackANDACurrent
63739-236GabapentinGabapentinMcKesson CorporationANDACurrent
63739-236GabapentinGabapentinMckesson Corporation DBA SKY PackaginngANDACurrent
63739-236GabapentinGabapentinMckesson Corporation DBA SKY PackaginngANDACurrent
63739-236GabapentinGabapentinMckesson Corporation DBA SKY PackaginngANDACurrent
63739-236GabapentinGabapentinMcKesson Corporation dba SKY PackagingANDACurrent
63739-591GabapentinGabapentinMcKesson CorporationANDACurrent
63739-591GabapentinGabapentinMckesson Corporation DBA SKY PackaginngANDACurrent
63739-591GabapentinGabapentinMckesson Corporation DBA SKY PackaginngANDACurrent
63739-591GabapentinGabapentinMckesson Corporation DBA SKY PackaginngANDACurrent
63739-591GabapentinGabapentinMcKesson Corporation dba SKY PackagingANDACurrent
63739-675GabapentinGabapentinMcKesson Corporation dba SKY PackagingANDACurrent
63739-675GabapentinGabapentinMcKesson CorporationANDACurrent
63739-689GabapentinGabapentinMcKesson Corporation dba SKY PackagingANDACurrent
63739-689GabapentinGabapentinMcKesson CorporationANDACurrent
63739-693GabapentinGabapentinMcKesson Corporation dba SKY PackagingANDACurrent
63739-693GabapentinGabapentinMcKesson CorporationANDACurrent
63739-984GabapentinGabapentinMcKesson CorporationANDACurrent
63739-984GabapentinGabapentinMckesson Corporation DBA SKY PackaginngANDACurrent
63739-984GabapentinGabapentinMckesson Corporation DBA SKY PackaginngANDACurrent