FDA.reportPublic FDA data

Application 075677

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACYCLOVIRACYCLOVIRCAPSULE;ORAL200MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-5789ACYCLOVIRACYCLOVIRMajor PharmaceuticalsANDACurrent
0904-5789ACYCLOVIRACYCLOVIRMajor PharmaceuticalsANDACurrent
0904-5789ACYCLOVIRACYCLOVIRMajor PharmaceuticalsANDACurrent
42291-017ACYCLOVIRACYCLOVIRAvKARE, Inc.ANDACurrent
42291-017ACYCLOVIRACYCLOVIRAvKAREANDACurrent
43063-826ACYCLOVIRACYCLOVIRPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-826ACYCLOVIRACYCLOVIRPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-826ACYCLOVIRACYCLOVIRPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-826ACYCLOVIRACYCLOVIRPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-826ACYCLOVIRACYCLOVIRPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-0595ACYCLOVIRACYCLOVIRA-S Medication SolutionsANDACurrent
53002-2450ACYCLOVIRACYCLOVIRRPK Pharmaceuticals, Inc.ANDACurrent
53002-2450ACYCLOVIRACYCLOVIRRPK Pharmaceuticals, Inc.ANDACurrent
55154-7629ACYCLOVIRACYCLOVIRCardinal Health, Inc.ANDACurrent
55154-7629ACYCLOVIRACYCLOVIRCardinal HealthANDACurrent
55154-7629ACYCLOVIRACYCLOVIRCardinal HealthANDACurrent
55154-7629ACYCLOVIRACYCLOVIRCardinal Health 107, LLCANDACurrent
55154-7629ACYCLOVIRACYCLOVIRCardinal Health, Inc.ANDACurrent
60429-012ACYCLOVIRACYCLOVIRGolden State Medical Supply, Inc.ANDACurrent
60429-012ACYCLOVIRACYCLOVIRGolden State Medical Supply, Inc.ANDACurrent
60505-0042ACYCLOVIRACYCLOVIRApotex Corp.ANDACurrent
60760-652ACYCLOVIRACYCLOVIRSt. Mary's Medical Park PharmacyANDACurrent
60760-652ACYCLOVIRACYCLOVIRSt. Mary's Medical Park PharmacyANDACurrent
60760-652ACYCLOVIRACYCLOVIRSt. Mary's Medical Park PharmacyANDACurrent
61919-331ACYCLOVIRACYCLOVIRDirect_RxANDACurrent
66267-006ACYCLOVIRACYCLOVIRNuCare Pharmaceuticals,Inc.ANDACurrent
67296-1108ACYCLOVIRACYCLOVIRRedPharm Drug, Inc.ANDACurrent
67296-1108ACYCLOVIRACYCLOVIRRedPharm Drug, Inc.ANDACurrent
67296-1108ACYCLOVIRACYCLOVIRRedPharm Drug, Inc.ANDACurrent
68084-107ACYCLOVIRACYCLOVIRAmerican Health PackagingANDACurrent
68084-107ACYCLOVIRACYCLOVIRAmerican Health PackagingANDACurrent
68084-107ACYCLOVIRACYCLOVIRAmerican Health PackagingANDACurrent
68084-107ACYCLOVIRACYCLOVIRAmerican Health PackagingANDACurrent
68788-6827ACYCLOVIRACYCLOVIRPreferred Pharmaceuticals Inc.ANDACurrent
70518-0315ACYCLOVIRACYCLOVIRREMEDYREPACK INC.ANDACurrent
70934-491ACYCLOVIRACYCLOVIRDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-243ACYCLOVIRACYCLOVIRProficient Rx LPANDACurrent
71205-243ACYCLOVIRACYCLOVIRProficient Rx LPANDACurrent
71205-243ACYCLOVIRACYCLOVIRProficient Rx LPANDACurrent
71335-0470ACYCLOVIRACYCLOVIRBryant Ranch PrepackANDACurrent
71335-0470ACYCLOVIRACYCLOVIRBryant Ranch PrepackANDACurrent