Application 050605

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFTINCEFUROXIME AXETILTABLET;ORALEQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002CEFTINCEFUROXIME AXETILTABLET;ORALEQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003CEFTINCEFUROXIME AXETILTABLET;ORALEQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66686SUPPL2021-03-09
66662SUPPL2021-03-09
58451SUPPL2019-04-26
58434SUPPL2019-04-26
50086SUPPL2017-10-18
50071SUPPL2017-10-17
45977SUPPL2016-12-01
45950SUPPL2016-11-23
30156SUPPL2015-08-28
17922SUPPL2015-08-27
30155SUPPL2015-07-07
39033SUPPL2015-07-01
30154SUPPL2014-09-23
30153SUPPL2014-09-23
39032SUPPL2014-09-22
39031SUPPL2014-09-22
30152SUPPL2007-07-27
17921SUPPL2007-07-24
30151SUPPL2004-06-07
17920SUPPL2004-06-07
7876SUPPL2002-07-24
17919SUPPL2002-04-11
7875SUPPL2002-04-11
17918SUPPL2002-03-29
7874SUPPL2002-03-29
30150SUPPL1999-08-24
22166SUPPL1999-08-24