FDA.reportPublic FDA data

Application 077487

Type
ANDA
Sponsor
TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FAMCICLOVIRFAMCICLOVIRTABLET;ORAL125MGNoNo
002FAMCICLOVIRFAMCICLOVIRTABLET;ORAL250MGNoNo
003FAMCICLOVIRFAMCICLOVIRTABLET;ORAL500MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-8117FamciclovirFamciclovirTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8117FamciclovirFamciclovirTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8117FamciclovirFamciclovirTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8118FamciclovirFamciclovirTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8118FamciclovirFamciclovirTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8118FamciclovirFamciclovirTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8119FamciclovirFamciclovirTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8119FamciclovirFamciclovirTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8119FamciclovirFamciclovirTeva Pharmaceuticals USA, Inc.ANDACurrent
42291-275FamciclovirFamciclovirAvKARE, Inc.ANDACurrent
42291-275FamciclovirFamciclovirAvKARE, Inc.ANDACurrent
42291-276FamciclovirFamciclovirAvKARE, Inc.ANDACurrent
42291-276FamciclovirFamciclovirAvKARE, Inc.ANDACurrent
42291-277FamciclovirFamciclovirAvKARE, Inc.ANDACurrent
42291-277FamciclovirFamciclovirAvKARE, Inc.ANDACurrent
42291-414FamciclovirFamciclovirAvKAREANDACurrent
42291-414FamciclovirFamciclovirAvKAREANDACurrent
42291-415FamciclovirFamciclovirAvKAREANDACurrent
42291-415FamciclovirFamciclovirAvKAREANDACurrent
42291-416FamciclovirFamciclovirAvKAREANDACurrent
42291-416FamciclovirFamciclovirAvKAREANDACurrent
55289-168FamciclovirFamciclovirPD-Rx Pharmaceuticals, InANDACurrent
55289-168FamciclovirFamciclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-168FamciclovirFamciclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-168FamciclovirFamciclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-168FamciclovirFamciclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31247ORIG2007-08-27
9052ORIG2007-07-05