FDA.reportPublic FDA data

Application 071135

Type
ANDA
Sponsor
MAYNE PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIAZEPAMDIAZEPAMTABLET;ORAL5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-5880DiazepamDiazepamMajor PharmaceuticalsANDACurrent
0904-5880DiazepamDiazepamMajor PharmaceuticalsANDACurrent
35356-716DiazepamDiazepamLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
43063-887DiazepamDiazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-887DiazepamDiazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-278DiazepamDiazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
45865-482DiazepamDiazepamMedsource PharmaceuticalsANDACurrent
50090-2995DiazepamDiazepamA-S Medication SolutionsANDACurrent
51862-063DiazepamDiazepamMayne PharmaANDACurrent
51862-063DiazepamDiazepamMayne PharmaANDACurrent
51862-063DiazepamDiazepamMayne PharmaANDACurrent
51862-063DiazepamDiazepamMayne PharmaANDACurrent
51862-063DiazepamDiazepamMayne PharmaANDACurrent
51862-942DiazepamDiazepamMayne PharmaANDACurrent
51862-942DiazepamDiazepamMayne PharmaANDACurrent
51862-942DiazepamDiazepamMayne PharmaANDACurrent
51862-942DiazepamDiazepamMayne PharmaANDACurrent
52959-047DIAZEPAMDIAZEPAMH.J. Harkins Company, Inc.ANDACurrent
55154-1492DiazepamDiazepamCardinal HealthANDACurrent
55154-7885DiazepamDiazepamCardinal HealthANDACurrent
55700-439DiazepamDiazepamLake Erie Medical DBA Quality Care Products LLCANDACurrent
60760-934DiazepamDiazepamSt. Mary's Medical Park PharmacyANDACurrent
61919-088DIAZEPAMDIAZEPAMDIRECT RXANDACurrent
61919-088DIAZEPAMDIAZEPAMDirect_RxANDACurrent
61919-088DIAZEPAMDIAZEPAMDirect_RxANDACurrent
61919-088DIAZEPAMDIAZEPAMDirect_RxANDACurrent
61919-367DiazepamDiazepamDirect RxANDACurrent
63187-867DiazepamDiazepamProficient Rx LPANDACurrent
63187-867DiazepamDiazepamProficient Rx LPANDACurrent
63739-073DiazepamDiazepamMcKesson CorporationANDACurrent
63739-073DiazepamDiazepamMcKesson Corporation dba SKY PackagingANDACurrent
63739-073DiazepamDiazepamMcKesson Corporation dba SKY PackagingANDACurrent
63739-073DiazepamDiazepamMcKesson Corporation dba SKY PackagingANDACurrent
66267-069DiazepamDiazepamNuCare Pharmaceuticals, Inc.ANDACurrent
66267-069DiazepamDiazepamNuCare Pharmaceuticals, Inc.ANDACurrent
66267-776DiazepamDiazepamNuCare Pharmaceuticals, Inc.ANDACurrent
66267-776DiazepamDiazepamNuCare Pharmaceuticals, Inc.ANDACurrent
67046-941DiazepamDiazepamContract Pharmacy Services-PAANDACurrent
67046-946DiazepamDiazepamContract Pharmacy Services-PAANDACurrent
67296-0506DiazepamdiazepamRedPharm Drug Inc.ANDACurrent
67296-1349DiazepamDiazepamRedPharm Drug, Inc.ANDACurrent
67296-1349DiazepamDiazepamRedPharm Drug, Inc.ANDACurrent
67544-019DiazepamDiazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
68071-2826DiazepamDiazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2828DiazepamDiazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3270DiazepamDiazepamNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3270DiazepamDiazepamNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3330DiazepamDiazepamNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3330DiazepamDiazepamNuCare Pharmaceuticals, Inc.ANDACurrent
68788-6851DiazepamDiazepamPreferred Pharmaceuticals Inc.ANDACurrent
68788-6851DiazepamDiazepamPreferred Pharmaceuticals Inc.ANDACurrent
68788-6851DiazepamDiazepamPreferred Pharmaceuticals Inc.ANDACurrent
68788-8281DiazepamDiazepamPreferred Pharmaceuticals Inc.ANDACurrent
71335-0495DiazepamDiazepamBryant Ranch PrepackANDACurrent
71335-0495DiazepamDiazepamBryant Ranch PrepackANDACurrent
71335-0495DiazepamDiazepamBryant Ranch PrepackANDACurrent
71335-0495DiazepamDiazepamBryant Ranch PrepackANDACurrent
71335-1627DiazepamDiazepamBryant Ranch PrepackANDACurrent
71335-2197DiazepamDiazepamBryant Ranch PrepackANDACurrent
71610-459DiazepamDiazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-459DiazepamDiazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-459DiazepamDiazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-459DiazepamDiazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
72189-401ValiumDiazepamDirect_RxANDACurrent
72189-401ValiumDiazepamDirect_RxANDACurrent