FDA.reportPublic FDA data

Application 090162

Type
ANDA
Sponsor
UNICHEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOPIRAMATETOPIRAMATETABLET;ORAL25MGNoNo
002TOPIRAMATETOPIRAMATETABLET;ORAL50MGNoNo
003TOPIRAMATETOPIRAMATETABLET;ORAL100MGNoNo
004TOPIRAMATETOPIRAMATETABLET;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
29300-115topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-115topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-115topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-115topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-115topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-115topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-116topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-116topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-116topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-116topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-116topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-116topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-117topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-117topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-117topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-117topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-117topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-117topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-118topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-118topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-118topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-118topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-118topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-118topiramatetopiramateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
50090-2102topiramatetopiramateA-S Medication SolutionsANDACurrent
50090-2102topiramatetopiramateA-S Medication SolutionsANDACurrent
50090-2203topiramatetopiramateA-S Medication SolutionsANDACurrent
50090-2203topiramatetopiramateA-S Medication SolutionsANDACurrent
50090-2248topiramatetopiramateA-S Medication SolutionsANDACurrent
50090-2248topiramatetopiramateA-S Medication SolutionsANDACurrent
53808-1131topiramatetopiramateDOH CENTRAL PHARMACYANDACurrent
54569-6137topiramatetopiramateA-S Medication SolutionsANDACurrent
61919-189TOPAMAXTOPIRAMATEDIRECT RXANDACurrent
68071-4760topiramatetopiramateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4760topiramatetopiramateNuCare Pharmaceuticals,Inc.ANDACurrent
70518-1853topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-1853topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-2322topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-2322topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-2322topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-2322topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-2322topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-2498topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-2498topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-2498topiramatetopiramateREMEDYREPACK INC.ANDACurrent
70518-2498topiramatetopiramateREMEDYREPACK INC.ANDACurrent
71205-187topiramatetopiramateProficient Rx LPANDACurrent
71205-187topiramatetopiramateProficient Rx LPANDACurrent
71205-187topiramatetopiramateProficient Rx LPANDACurrent
71205-195topiramatetopiramateProficient Rx LPANDACurrent
71205-195topiramatetopiramateProficient Rx LPANDACurrent
71205-195topiramatetopiramateProficient Rx LPANDACurrent
71205-202topiramatetopiramateProficient Rx LPANDACurrent
71205-202topiramatetopiramateProficient Rx LPANDACurrent
71335-1064topiramatetopiramateBryant Ranch PrepackANDACurrent
71335-1064topiramatetopiramateBryant Ranch PrepackANDACurrent
71335-1064topiramatetopiramateBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23938ORIG2009-04-14