FDA.reportPublic FDA data

Application 022350

Type
NDA
Sponsor
ASTRAZENECA AB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ONGLYZASAXAGLIPTIN HYDROCHLORIDETABLET;ORALEQ 2.5MG BASEYesNo
002ONGLYZASAXAGLIPTIN HYDROCHLORIDETABLET;ORALEQ 5MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0310-6100ONGLYZASAXAGLIPTINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6100ONGLYZASAXAGLIPTINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6100ONGLYZASAXAGLIPTINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6100ONGLYZASAXAGLIPTINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6100ONGLYZASAXAGLIPTINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6100ONGLYZASAXAGLIPTINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6105ONGLYZASAXAGLIPTINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6105ONGLYZASAXAGLIPTINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6105ONGLYZASAXAGLIPTINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6105ONGLYZASAXAGLIPTINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6105ONGLYZASAXAGLIPTINAstraZeneca Pharmaceuticals LPNDACurrent
0310-6105ONGLYZASAXAGLIPTINAstraZeneca Pharmaceuticals LPNDACurrent
55154-6931ONGLYZASAXAGLIPTINCardinal Health 107, LLCNDACurrent
55154-6931ONGLYZASAXAGLIPTINCardinal HealthNDACurrent
55154-6931ONGLYZASAXAGLIPTINCardinal HealthNDACurrent
55154-6931ONGLYZASAXAGLIPTINCardinal HealthNDACurrent
55154-6931ONGLYZASAXAGLIPTINCardinal HealthNDACurrent
55154-6931ONGLYZASAXAGLIPTINCardinal HealthNDACurrent
55154-6931ONGLYZASAXAGLIPTINCardinal HealthNDACurrent
55154-6931ONGLYZASAXAGLIPTINCardinal HealthNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79900SUPPL 2024-10-15
79899SUPPL 2024-10-15
79898SUPPL 2024-10-15
59277SUPPL2019-07-08
59276SUPPL2019-07-08
59213SUPPL2019-07-02
47498SUPPL2017-03-08
47475SUPPL2017-03-07
47359SUPPL2017-02-28
46937SUPPL2017-01-24
46919SUPPL2017-01-18
38611SUPPL2016-04-07
7282SUPPL2016-04-07
38612SUPPL2015-09-04
7283SUPPL2015-09-01
17283SUPPL2013-06-04
7281SUPPL2013-05-29
7280SUPPL2012-03-15
17282SUPPL2011-12-23
29636SUPPL2011-12-22
29637SUPPL2011-11-17
38610SUPPL2011-11-16
38609SUPPL2011-02-24
29635SUPPL2011-02-24
17281SUPPL2011-02-24
7279SUPPL2011-02-24
44740ORIG2009-09-29
21999ORIG2009-09-29
38608ORIG2009-08-14
29634ORIG2009-08-06