Application 020584

Type
NDA
Sponsor
WYETH PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LODINE XLETODOLACTABLET, EXTENDED RELEASE;ORAL400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo
002LODINE XLETODOLACTABLET, EXTENDED RELEASE;ORAL600MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003LODINE XLETODOLACTABLET, EXTENDED RELEASE;ORAL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
34884SUPPL2006-01-20
25233SUPPL2006-01-20
34883SUPPL2005-05-26
34882SUPPL2005-05-26
25232SUPPL2005-05-26
12773SUPPL2005-05-26
2782SUPPL2005-05-26
2781SUPPL2005-05-26
41447SUPPL2003-09-11
20738SUPPL2001-11-09
20737SUPPL2001-07-18
25231SUPPL2000-08-11
12772SUPPL2000-08-11
34881SUPPL1999-05-27
25230SUPPL1999-05-27