FDA.reportPublic FDA data

Application 203834

Type
ANDA
Sponsor
HETERO LABS LTD V

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACYCLOVIRACYCLOVIRTABLET;ORAL400MGNoNo
002ACYCLOVIRACYCLOVIRTABLET;ORAL800MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-777AcyclovirAcyclovirCamber Pharmaceuticals, Inc.ANDACurrent
31722-777AcyclovirAcyclovirCamber Pharmaceuticals, Inc.ANDACurrent
31722-777AcyclovirAcyclovirCamber Pharmaceuticals, Inc.ANDACurrent
31722-778AcyclovirAcyclovirCamber Pharmaceuticals, Inc.ANDACurrent
31722-778AcyclovirAcyclovirCamber Pharmaceuticals, Inc.ANDACurrent
31722-778AcyclovirAcyclovirCamber Pharmaceuticals, Inc.ANDACurrent
43063-589AcyclovirAcyclovirPD-Rx Pharmaceuticals, InANDACurrent
43063-589AcyclovirAcyclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-589AcyclovirAcyclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-589AcyclovirAcyclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-589AcyclovirAcyclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-589AcyclovirAcyclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-928AcyclovirAcyclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-928AcyclovirAcyclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-928AcyclovirAcyclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-928AcyclovirAcyclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-928AcyclovirAcyclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-928AcyclovirAcyclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-928AcyclovirAcyclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-928AcyclovirAcyclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-928AcyclovirAcyclovirPD-Rx Pharmaceuticals, InANDACurrent
50090-1567AcyclovirAcyclovirA-S Medication SolutionsANDACurrent
50090-1567AcyclovirAcyclovirA-S Medication SolutionsANDACurrent
50090-1567AcyclovirAcyclovirA-S Medication SolutionsANDACurrent
50090-1568AcyclovirAcyclovirA-S Medication SolutionsANDACurrent
50090-1568AcyclovirAcyclovirA-S Medication SolutionsANDACurrent
50090-1624AcyclovirAcyclovirA-S Medication SolutionsANDACurrent
50090-1624AcyclovirAcyclovirA-S Medication SolutionsANDACurrent
50090-1624AcyclovirAcyclovirA-S Medication SolutionsANDACurrent
50090-1624AcyclovirAcyclovirA-S Medication SolutionsANDACurrent
50090-1624AcyclovirAcyclovirA-S Medication SolutionsANDACurrent
51655-300acycloviracyclovirNorthwind Pharmaceuticals, LLCANDACurrent
53002-0270AcyclovirAcyclovirRPK Pharmaceuticals, Inc.ANDACurrent
53002-0270AcyclovirAcyclovirRPK Pharmaceuticals, Inc.ANDACurrent
54348-624AcyclovirACYCLOVIRPharmPak, Inc.ANDACurrent
54348-624AcyclovirACYCLOVIRPharmPak, Inc.ANDACurrent
54348-627AcyclovirAcyclovirPharmPak, Inc.ANDACurrent
54348-627AcyclovirAcyclovirPharmPak, Inc.ANDACurrent
55700-786AcyclovirAcyclovirQuality Care Products, LLCANDACurrent
55700-786AcyclovirAcyclovirQuality Care Products, LLCANDACurrent
61919-530AcyclovirAcyclovirDirect RxANDACurrent
61919-530AcyclovirAcyclovirDirect RxANDACurrent
61919-530AcyclovirAcyclovirDirect RxANDACurrent
61919-654ACYCLOVIRACYCLOVIRDirectRXANDACurrent
63187-253AcyclovirAcyclovirProficient Rx LPANDACurrent
63187-253AcyclovirAcyclovirProficient Rx LPANDACurrent
63187-253AcyclovirAcyclovirProficient Rx LPANDACurrent
63187-253AcyclovirAcyclovirProficient Rx LPANDACurrent
63187-574AcyclovirAcyclovirProficient Rx LPANDACurrent
63187-574AcyclovirAcyclovirProficient Rx LPANDACurrent
63187-574AcyclovirAcyclovirProficient Rx LPANDACurrent
67046-335AcyclovirAcyclovirContract Pharmacy Services-PAANDACurrent
67296-1089AcyclovirAcyclovirRedPharm Drug, Inc.ANDACurrent
67296-1089AcyclovirAcyclovirRedPharm Drug, Inc.ANDACurrent
67296-1089AcyclovirAcyclovirRedPharm Drug, Inc.ANDACurrent
67296-1300AcyclovirAcyclovirRedPharm Drug, Inc.ANDACurrent
67296-1300AcyclovirAcyclovirRedPharm Drug, Inc.ANDACurrent
67296-1300AcyclovirAcyclovirRedPharm Drug, Inc.ANDACurrent
68071-1841AcyclovirAcyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1841AcyclovirAcyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3155AcyclovirAcyclovirNuCarePharmaceuticals, Inc.ANDACurrent
68071-3222AcyclovirAcyclovirNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3222AcyclovirAcyclovirNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4799AcyclovirAcyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4799AcyclovirAcyclovirNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7575AcyclovirAcyclovirPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7575AcyclovirAcyclovirPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7575AcyclovirAcyclovirPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7576AcyclovirAcyclovirPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7576AcyclovirAcyclovirPreferred Pharmaceuticals, Inc.ANDACurrent
70518-2117AcyclovirAcyclovirREMEDYREPACK INC.ANDACurrent
70518-2117AcyclovirAcyclovirREMEDYREPACK INC.ANDACurrent
70518-2117AcyclovirAcyclovirREMEDYREPACK INC.ANDACurrent
70518-2117AcyclovirAcyclovirREMEDYREPACK INC.ANDACurrent
70518-2455AcyclovirAcyclovirREMEDYREPACK INC.ANDACurrent
70518-2455AcyclovirAcyclovirREMEDYREPACK INC.ANDACurrent
70518-2455AcyclovirAcyclovirREMEDYREPACK INC.ANDACurrent
70518-2455AcyclovirAcyclovirREMEDYREPACK INC.ANDACurrent
70518-2455AcyclovirAcyclovirREMEDYREPACK INC.ANDACurrent
70518-2455AcyclovirAcyclovirREMEDYREPACK INC.ANDACurrent