FDA.reportPublic FDA data

Application 079132

Type
ANDA
Sponsor
JUBILANT CADISTA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LAMOTRIGINELAMOTRIGINETABLET;ORAL25MGNoNo
002LAMOTRIGINELAMOTRIGINETABLET;ORAL100MGNoNo
003LAMOTRIGINELAMOTRIGINETABLET;ORAL150MGNoNo
004LAMOTRIGINELAMOTRIGINETABLET;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33261-647LamotrigineLamotrigineAidarex Pharmaceuticals LLCANDACurrent
33261-946LamotrigineLamotrigineAidarex Pharmaceuticals LLCANDACurrent
42291-366LamotrigineLamotrigineAvKARE, Inc.ANDACurrent
42291-366LamotrigineLamotrigineAvKARE, Inc.ANDACurrent
42291-366LamotrigineLamotrigineAvKAREANDACurrent
42291-367LamotrigineLamotrigineAvKARE, Inc.ANDACurrent
42291-367LamotrigineLamotrigineAvKARE, Inc.ANDACurrent
42291-367LamotrigineLamotrigineAvKAREANDACurrent
42291-368LamotrigineLamotrigineAvKARE, Inc.ANDACurrent
42291-368LamotrigineLamotrigineAvKARE, Inc.ANDACurrent
42291-368LamotrigineLamotrigineAvKAREANDACurrent
42291-369LamotrigineLamotrigineAvKARE, Inc.ANDACurrent
42291-369LamotrigineLamotrigineAvKAREANDACurrent
42291-369LamotrigineLamotrigineAvKARE, Inc.ANDACurrent
50268-461LamotrigineLamotrigineAvPAKANDACurrent
50268-462LamotrigineLamotrigineAvPAKANDACurrent
50268-463LamotrigineLamotrigineAvPAKANDACurrent
50268-464LamotrigineLamotrigineAvPAKANDACurrent
50436-3995LamotrigineLamotrigineUnit Dose ServicesANDACurrent
50436-3996LamotrigineLamotrigineUnit Dose ServicesANDACurrent
59746-245LamotrigineLamotrigineJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
59746-245LamotrigineLamotrigineJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
59746-245LamotrigineLamotrigineJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
59746-245LamotrigineLamotrigineJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
59746-246LamotrigineLamotrigineJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
59746-246LamotrigineLamotrigineJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
59746-246LamotrigineLamotrigineJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
59746-246LamotrigineLamotrigineJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
59746-247LamotrigineLamotrigineJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
59746-247LamotrigineLamotrigineJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
59746-247LamotrigineLamotrigineJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
59746-247LamotrigineLamotrigineJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
59746-248LamotrigineLamotrigineJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
59746-248LamotrigineLamotrigineJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
59746-248LamotrigineLamotrigineJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
59746-248LamotrigineLamotrigineJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
63629-4697LamotrigineLamotrigineBryant Ranch PrepackANDACurrent
63629-4697LamotrigineLamotrigineBryant Ranch PrepackANDACurrent
68788-7465LamotrigineLamotriginePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7465LamotrigineLamotriginePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9526LamotrigineLamotriginePreferred Pharmaceuticals, Inc.ANDACurrent
70518-2093LamotrigineLamotrigineREMEDYREPACK INC.ANDACurrent
70518-2503LamotrigineLamotrigineREMEDYREPACK INC.ANDACurrent
70518-2503LamotrigineLamotrigineREMEDYREPACK INC.ANDACurrent
70518-2503LamotrigineLamotrigineREMEDYREPACK INC.ANDACurrent
70518-2503LamotrigineLamotrigineREMEDYREPACK INC.ANDACurrent
70518-2503LamotrigineLamotrigineREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31415ORIG2012-02-14