FDA.reportPublic FDA data

Application 050590

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TIMENTINCLAVULANATE POTASSIUM; TICARCILLIN DISODIUMINJECTABLE;INJECTIONEQ 100MG BASE/VIAL;EQ 3GM BASE/VIALNoNo
002TIMENTINCLAVULANATE POTASSIUM; TICARCILLIN DISODIUMINJECTABLE;INJECTIONEQ 200MG BASE/VIAL;EQ 3GM BASE/VIALNoNo
003TIMENTINCLAVULANATE POTASSIUM; TICARCILLIN DISODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIAL;EQ 30GM BASE/VIALNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
17912SUPPL2014-06-17
7861SUPPL2014-06-17
17911SUPPL2013-10-01
7860SUPPL2013-10-01
30137SUPPL2012-10-09
39018SUPPL2012-10-05
17910SUPPL2011-06-14
17909SUPPL2011-06-14
30136SUPPL2011-06-13
30135SUPPL2011-06-13
30134SUPPL2010-12-28
7859SUPPL2010-12-28
39017SUPPL2010-12-26
17908SUPPL2010-12-26
30133SUPPL2008-12-19
39016SUPPL2008-06-05
7858SUPPL2008-04-22
30132SUPPL2007-03-23
39015SUPPL2007-03-16
30131SUPPL2004-12-02
30129SUPPL2002-05-17
30130SUPPL2002-03-18