FDA.reportPublic FDA data

Application 200327

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TEFLAROCEFTAROLINE FOSAMILPOWDER;INTRAVENOUS400MG/VIALYesNo
002TEFLAROCEFTAROLINE FOSAMILPOWDER;INTRAVENOUS600MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0456-0400Teflaroceftaroline fosamilAllergan, Inc.NDACurrent
0456-0400Teflaroceftaroline fosamilAllergan, Inc.NDACurrent
0456-0400Teflaroceftaroline fosamilAllergan, Inc.NDACurrent
0456-0400Teflaroceftaroline fosamilAllergan, Inc.NDACurrent
0456-0400Teflaroceftaroline fosamilAllergan, Inc.NDACurrent
0456-0400Teflaroceftaroline fosamilAllergan, Inc.NDACurrent
0456-0400Teflaroceftaroline fosamilAllergan, Inc.NDACurrent
0456-0400Teflaroceftaroline fosamilAllergan, Inc.NDACurrent
0456-0400Teflaroceftaroline fosamilAllergan, Inc.NDACurrent
0456-0400Teflaroceftaroline fosamilAllergan, Inc.NDACurrent
0456-0400Teflaroceftaroline fosamilAllergan, Inc.NDACurrent
0456-0400Teflaroceftaroline fosamilAllergan, Inc.NDACurrent
0456-0600Teflaroceftaroline fosamilAllergan, Inc.NDACurrent
0456-0600Teflaroceftaroline fosamilAllergan, Inc.NDACurrent
0456-0600Teflaroceftaroline fosamilAllergan, Inc.NDACurrent
0456-0600Teflaroceftaroline fosamilAllergan, Inc.NDACurrent
0456-0600Teflaroceftaroline fosamilAllergan, Inc.NDACurrent
0456-0600Teflaroceftaroline fosamilAllergan, Inc.NDACurrent
0456-0600Teflaroceftaroline fosamilAllergan, Inc.NDACurrent
0456-0600Teflaroceftaroline fosamilAllergan, Inc.NDACurrent
0456-0600Teflaroceftaroline fosamilAllergan, Inc.NDACurrent
0456-0600Teflaroceftaroline fosamilAllergan, Inc.NDACurrent
0456-0600Teflaroceftaroline fosamilAllergan, Inc.NDACurrent
0456-0600Teflaroceftaroline fosamilAllergan, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69498SUPPL2021-12-07
69467SUPPL2021-12-03
65427SUPPL2020-12-01
65367SUPPL2020-11-30
60212SUPPL2019-10-03
60016SUPPL2019-09-17
40020SUPPL2016-06-01
18960SUPPL2016-06-01
32022SUPPL2016-05-31
9818SUPPL2016-05-31
40019SUPPL2015-09-04
32021SUPPL2015-09-04
32020SUPPL2015-09-04
18959SUPPL2015-09-04
9817SUPPL2015-09-04
40018SUPPL2015-03-26
9816SUPPL2015-03-23
32019SUPPL2013-12-17
18958SUPPL2013-12-17
18957SUPPL2013-06-04
32018SUPPL2013-05-30
18956SUPPL2012-10-24
9815SUPPL2012-10-24
9814SUPPL2012-05-24
40017SUPPL2012-05-07
9812SUPPL2011-07-06
18954SUPPL2011-06-30
9813SUPPL2011-03-16
18955SUPPL2011-03-14
44820ORIG2010-12-14
43345ORIG2010-12-13
32017ORIG2010-11-03
40016ORIG2010-10-29
67065SUPPL1900-01-01
62877SUPPL1900-01-01
52416SUPPL1900-01-01
52415SUPPL1900-01-01
52414SUPPL1900-01-01
52413SUPPL1900-01-01
52412SUPPL1900-01-01
52411SUPPL1900-01-01
52410SUPPL1900-01-01
52409SUPPL1900-01-01