FDA.reportPublic FDA data

Application 075410

Type
ANDA
Sponsor
LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMEPRAZOLEOMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL10MGNoNo
002OMEPRAZOLEOMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL20MGNoNo
003OMEPRAZOLEOMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16853-1308OMESECOmeprazoleCorporacion InfarmasaANDACurrent
21695-097OmeprazoleomeprazoleRebel Distributors Corp.ANDACurrent
21695-098OmeprazoleomeprazoleRebel Distributors Corp.ANDACurrent
35356-644OmeprazoleomeprazoleLake Erie Medical DBA Quality Care Products LLCANDACurrent
43353-829OmeprazoleomeprazoleAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-829OmeprazoleomeprazoleAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-829OmeprazoleomeprazoleAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-0828OmeprazoleomeprazoleA-S Medication SolutionsANDACurrent
50090-0828OmeprazoleomeprazoleA-S Medication SolutionsANDACurrent
50090-1370OmeprazoleomeprazoleA-S Medication SolutionsANDACurrent
50090-1370OmeprazoleomeprazoleA-S Medication SolutionsANDACurrent
50090-1370OmeprazoleomeprazoleA-S Medication SolutionsANDACurrent
50090-1370OmeprazoleomeprazoleA-S Medication SolutionsANDACurrent
50090-4595OmeprazoleomeprazoleA-S Medication SolutionsANDACurrent
50090-4907OmeprazoleomeprazoleA-S Medication SolutionsANDACurrent
50090-4907OmeprazoleomeprazoleA-S Medication SolutionsANDACurrent
50090-5054OmeprazoleomeprazoleA-S Medication SolutionsANDACurrent
50090-5054OmeprazoleomeprazoleA-S Medication SolutionsANDACurrent
50268-619OmeprazoleomeprazoleAvPAKANDACurrent
50268-619OmeprazoleomeprazoleAvPAKANDACurrent
50268-620OmeprazoleomeprazoleAvPAKANDACurrent
50268-620OmeprazoleomeprazoleAvPAKANDACurrent
50436-3125OmeprazoleomeprazoleUnit Dose ServicesANDACurrent
51407-256OmeprazoleomeprazoleGolden State Medical SupplyANDACurrent
51407-256OmeprazoleomeprazoleGolden State Medical SupplyANDACurrent
51407-256OmeprazoleomeprazoleGolden State Medical SupplyANDACurrent
51407-256OmeprazoleomeprazoleGolden State Medical Supply, Inc.ANDACurrent
51407-256OmeprazoleomeprazoleGolden State Medical Supply, Inc.ANDACurrent
51407-303OmeprazoleomeprazoleGolden State Medical SupplyANDACurrent
51407-303OmeprazoleomeprazoleGolden State Medical SupplyANDACurrent
51407-303OmeprazoleomeprazoleGolden State Medical SupplyANDACurrent
51407-303OmeprazoleomeprazoleGolden State Medical Supply, Inc.ANDACurrent
51407-303OmeprazoleomeprazoleGolden State Medical Supply, Inc.ANDACurrent
53002-2688OmeprazoleomeprazoleRPK Pharmaceuticals, Inc.ANDACurrent
53217-353OmeprazoleomeprazoleAidarex Pharmaceuticals LLCANDACurrent
60760-395OmeprazoleomeprazoleSt. Mary's Medical Park PharmacyANDACurrent
60760-489OmeprazoleomeprazoleSt. Mary's Medical Park PharmacyANDACurrent
60760-489OmeprazoleomeprazoleSt. Mary's Medical Park PharmacyANDACurrent
62175-114OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-114OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-114OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-114OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-114OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-114OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-114OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-114OmeprazoleomeprazoleLannett Company, Inc..ANDACurrent
62175-118OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-118OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-118OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-118OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-118OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-118OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-118OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-118OmeprazoleomeprazoleLannett Company, Inc..ANDACurrent
62175-136OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-136OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-136OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-136OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-136OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-136OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-136OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-136OmeprazoleomeprazoleLannett Company, Inc..ANDACurrent
63739-358OmeprazoleomeprazoleMcKesson Corporation dba SKY PackagingANDACurrent
63739-358OmeprazoleomeprazoleMcKesson Corporation dba SKY PackagingANDACurrent
63739-358OmeprazoleomeprazoleMcKesson CorporationANDACurrent
63739-445OmeprazoleomeprazoleMcKesson Corporation dba SKY PackagingANDACurrent
63739-445OmeprazoleomeprazoleMcKesson Corporation dba SKY PackagingANDACurrent
63739-445OmeprazoleomeprazoleMcKesson CorporationANDACurrent
63874-553OmeprazoleomeprazoleAltura Pharmaceuticals, Inc.ANDACurrent
65084-445OmeprazoleomeprazoleMcKesson Corporation dba RX PakANDACurrent
67046-520OmeprazoleOmeprazoleContract Pharmacy Services-PAANDACurrent
67544-510OmeprazoleomeprazoleAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-510OmeprazoleomeprazoleAphena Pharma Solutions - Tennessee, LLCANDACurrent
68071-2243OmeprazoleomeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2243OmeprazoleomeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2358OmeprazoleomeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2499OmeprazoleomeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4025OmeprazoleomeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4025OmeprazoleomeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4140OmeprazoleomeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42992ORIG2005-07-22
8657ORIG2004-06-28