FDA.reportPublic FDA data

Application 021821

Type
NDA
Sponsor
PF PRISM CV

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TYGACILTIGECYCLINEPOWDER;INTRAVENOUS50MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0008-4990TygacilTIGECYCLINEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-4990TygacilTIGECYCLINEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-4990TygacilTIGECYCLINEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-4990TygacilTIGECYCLINEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-4990TygacilTIGECYCLINEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-4990TygacilTIGECYCLINEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-4990TygacilTIGECYCLINEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-4990TygacilTIGECYCLINEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-4990TygacilTIGECYCLINEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-4994TygacilTIGECYCLINEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-4994TygacilTIGECYCLINEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-4994TygacilTIGECYCLINEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-4994TygacilTIGECYCLINEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-4994TygacilTIGECYCLINEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-4994TygacilTIGECYCLINEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-4994TygacilTIGECYCLINEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81866SUPPL 2025-04-08
81796SUPPL 2025-04-02
63685SUPPL2020-06-24
63679SUPPL2020-06-24
61601SUPPL2020-01-17
61588SUPPL2020-01-17
53716SUPPL2018-04-17
53703SUPPL2018-04-17
37718SUPPL2016-07-14
6263SUPPL2016-06-30
28662SUPPL2016-06-01
16425SUPPL2016-06-01
37719SUPPL2016-01-26
6264SUPPL2016-01-21
21833SUPPL2014-01-16
21832SUPPL2014-01-16
6262SUPPL2013-10-01
6260SUPPL2013-10-01
37716SUPPL2013-09-27
37714SUPPL2013-09-27
28661SUPPL2013-05-28
37717SUPPL2013-05-24
44152ORIG2011-12-21
28660SUPPL2010-07-23
6261SUPPL2010-07-23
6259SUPPL2010-07-23
37715SUPPL2010-07-19
37712SUPPL2010-07-19
37713SUPPL2010-07-16
6258SUPPL2009-06-30
37711SUPPL2009-03-25
28658SUPPL2009-03-25
16423SUPPL2009-03-25
16421SUPPL2009-03-25
6257SUPPL2009-03-25
6256SUPPL2009-03-25
28657SUPPL2009-02-13
16422SUPPL2009-02-10
37710SUPPL2009-02-04
16424SUPPL2009-02-04
28659SUPPL2009-02-03
28656SUPPL2009-02-03
28655SUPPL2009-02-03
37709SUPPL2007-05-29
28654SUPPL2007-05-29
6255SUPPL2007-04-09
37708SUPPL2007-04-06
6254SUPPL2007-02-02
28653SUPPL2006-07-21
6253SUPPL2006-07-21
21831ORIG2005-08-24
6252ORIG2005-06-21
16420ORIG2005-06-17