FDA.reportPublic FDA data

Application 077135

Type
ANDA
Sponsor
CIPLA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDETABLET;ORALEQ 500MG BASENoNo
002VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDETABLET;ORALEQ 1GM BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-832Valacyclovir HydrochlorideValacyclovir HydrochlorideRebel Distributors CorpANDACurrent
21695-965Valacyclovir HydrochlorideValacyclovir HydrochlorideRebel Distributors CorpANDACurrent
43063-778Valacyclovir hydrochlorideValacyclovir hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-778Valacyclovir hydrochlorideValacyclovir hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-778Valacyclovir hydrochlorideValacyclovir hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-778Valacyclovir hydrochlorideValacyclovir hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-778Valacyclovir hydrochlorideValacyclovir hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-778Valacyclovir hydrochlorideValacyclovir hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-1735Valacyclovir hydrochlorideValacyclovir hydrochlorideA-S Medication SolutionsANDACurrent
50090-1735Valacyclovir hydrochlorideValacyclovir hydrochlorideA-S Medication SolutionsANDACurrent
50090-1735Valacyclovir hydrochlorideValacyclovir hydrochlorideA-S Medication SolutionsANDACurrent
50090-1735Valacyclovir hydrochlorideValacyclovir hydrochlorideA-S Medication SolutionsANDACurrent
50090-2101Valacyclovir hydrochlorideValacyclovir hydrochlorideA-S Medication SolutionsANDACurrent
50436-0153Valacyclovir hydrochlorideValacyclovir hydrochlorideUnit Dose ServicesANDACurrent
50436-0153Valacyclovir hydrochlorideValacyclovir hydrochlorideUnit Dose ServicesANDACurrent
50436-0154Valacyclovir hydrochlorideValacyclovir hydrochlorideUnit Dose ServicesANDACurrent
52959-303Valacyclovir HydrochlorideValacyclovir HydrochlorideH.J. Harkins Company, Inc.ANDACurrent
61919-515VALACYCLOVIRVALACYCLOVIRDirectRXANDACurrent
63187-627Valacyclovir hydrochlorideValacyclovir hydrochlorideProficient Rx LPANDACurrent
63187-627Valacyclovir hydrochlorideValacyclovir hydrochlorideProficient Rx LPANDACurrent
67296-1226Valacyclovir hydrochlorideValacyclovir hydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1226Valacyclovir hydrochlorideValacyclovir hydrochlorideRedPharm Drug, Inc.ANDACurrent
68071-1842Valacyclovir hydrochlorideValacyclovir hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1842Valacyclovir hydrochlorideValacyclovir hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2099Valacyclovir hydrochlorideValacyclovir hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2110Valacyclovir hydrochlorideValacyclovir hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3037Valacyclovir hydrochlorideValacyclovir hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3037Valacyclovir hydrochlorideValacyclovir hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3037Valacyclovir hydrochlorideValacyclovir hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68788-6345Valacyclovir hydrochlorideValacyclovir hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6345Valacyclovir hydrochlorideValacyclovir hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6345Valacyclovir hydrochlorideValacyclovir hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6345Valacyclovir hydrochlorideValacyclovir hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6896Valacyclovir hydrochlorideValacyclovir hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6896Valacyclovir hydrochlorideValacyclovir hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6896Valacyclovir hydrochlorideValacyclovir hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6896Valacyclovir hydrochlorideValacyclovir hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6896Valacyclovir hydrochlorideValacyclovir hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
69097-153Valacyclovir hydrochlorideValacyclovir hydrochlorideCipla USA Inc.ANDACurrent
69097-153Valacyclovir hydrochlorideValacyclovir hydrochlorideCipla USA Inc.ANDACurrent
69097-153Valacyclovir hydrochlorideValacyclovir hydrochlorideCipla USA Inc.ANDACurrent
69097-153Valacyclovir hydrochlorideValacyclovir hydrochlorideCipla USA Inc.ANDACurrent
69097-153Valacyclovir hydrochlorideValacyclovir hydrochlorideCipla USA Inc.ANDACurrent
69097-154Valacyclovir hydrochlorideValacyclovir hydrochlorideCipla USA Inc.ANDACurrent
69097-154Valacyclovir hydrochlorideValacyclovir hydrochlorideCipla USA Inc.ANDACurrent
69097-154Valacyclovir hydrochlorideValacyclovir hydrochlorideCipla USA Inc.ANDACurrent
69097-154Valacyclovir hydrochlorideValacyclovir hydrochlorideCipla USA Inc.ANDACurrent
69097-154Valacyclovir hydrochlorideValacyclovir hydrochlorideCipla USA Inc.ANDACurrent
70518-1106Valacyclovir hydrochlorideValacyclovir hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1990Valacyclovir hydrochlorideValacyclovir hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1990Valacyclovir hydrochlorideValacyclovir hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1990Valacyclovir hydrochlorideValacyclovir hydrochlorideREMEDYREPACK INC.ANDACurrent
70934-180Valacyclovir hydrochlorideValacyclovir hydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-180Valacyclovir hydrochlorideValacyclovir hydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-301Valacyclovir hydrochlorideValacyclovir hydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-301Valacyclovir hydrochlorideValacyclovir hydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0021Valacyclovir hydrochlorideValacyclovir hydrochlorideBryant Ranch PrepackANDACurrent
71335-0021Valacyclovir hydrochlorideValacyclovir hydrochlorideBryant Ranch PrepackANDACurrent
71335-0021Valacyclovir hydrochlorideValacyclovir hydrochlorideBryant Ranch PrepackANDACurrent
71335-0123Valacyclovir hydrochlorideValacyclovir hydrochlorideBryant Ranch PrepackANDACurrent
71335-0123Valacyclovir hydrochlorideValacyclovir hydrochlorideBryant Ranch PrepackANDACurrent
71335-0123Valacyclovir hydrochlorideValacyclovir hydrochlorideBryant Ranch PrepackANDACurrent
71335-1155Valacyclovir hydrochlorideValacyclovir hydrochlorideBryant Ranch PrepackANDACurrent
71335-1155Valacyclovir hydrochlorideValacyclovir hydrochlorideBryant Ranch PrepackANDACurrent
76519-1147VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEH.J. Harkins Company, Inc.ANDACurrent