FDA.reportPublic FDA data

Application 201506

Type
ANDA
Sponsor
JUBILANT GENERICS

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
10544-937valacyclovir hydrochloridevalacyclovir hydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
50436-3240valacyclovir hydrochloridevalacyclovir hydrochlorideUnit Dose ServicesANDACurrent
50436-3250valacyclovir hydrochloridevalacyclovir hydrochlorideUnit Dose ServicesANDACurrent
53002-0060valacyclovir hydrochloridevalacyclovir hydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-0060valacyclovir hydrochloridevalacyclovir hydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-0060valacyclovir hydrochloridevalacyclovir hydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
55700-345valacyclovir hydrochloridevalacyclovir hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-345valacyclovir hydrochloridevalacyclovir hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
59746-324valacyclovir hydrochloridevalacyclovir hydrochlorideJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-324valacyclovir hydrochloridevalacyclovir hydrochlorideJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-324valacyclovir hydrochloridevalacyclovir hydrochlorideJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-325valacyclovir hydrochloridevalacyclovir hydrochlorideJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-325valacyclovir hydrochloridevalacyclovir hydrochlorideJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-325valacyclovir hydrochloridevalacyclovir hydrochlorideJubilant Cadista Pharmaceuticals Inc.ANDACurrent
61919-066ValacyclovirValacyclovirDirect RxANDACurrent
63187-538valacyclovir hydrochloridevalacyclovir hydrochlorideProficient Rx LPANDACurrent
63187-538valacyclovir hydrochloridevalacyclovir hydrochlorideProficient Rx LPANDACurrent
67296-1076valacyclovir hydrochloridevalacyclovir hydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1076valacyclovir hydrochloridevalacyclovir hydrochlorideRedPharm Drug, Inc.ANDACurrent
68788-6379valacyclovir hydrochloridevalacyclovir hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-9984valacyclovir hydrochloridevalacyclovir hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
70518-2346valacyclovir hydrochloridevalacyclovir hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2346valacyclovir hydrochloridevalacyclovir hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2346valacyclovir hydrochloridevalacyclovir hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2346valacyclovir hydrochloridevalacyclovir hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2346valacyclovir hydrochloridevalacyclovir hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2346valacyclovir hydrochloridevalacyclovir hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2928valacyclovir hydrochloridevalacyclovir hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2928valacyclovir hydrochloridevalacyclovir hydrochlorideREMEDYREPACK INC.ANDACurrent
72189-037VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEDIRECT RXANDACurrent
72189-037VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEDIRECT RXANDACurrent
72189-037VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEDIRECT RXANDACurrent
72189-037VALACYCLOVIR HYDROCHLORIDEVALACYCLOVIR HYDROCHLORIDEDIRECT RXANDACurrent