FDA.reportPublic FDA data

Application 017377

Type
NDA
Sponsor
SUN PHARM INDUSTRIES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BACTRIMSULFAMETHOXAZOLE; TRIMETHOPRIMTABLET;ORAL400MG;80MGYesNo
002BACTRIM DSSULFAMETHOXAZOLE; TRIMETHOPRIMTABLET;ORAL800MG;160MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49708-145Bactrimsulfamethoxazole and TrimethoprimSun Pharmaceutical Industries, IncNDACurrent
49708-145Bactrimsulfamethoxazole and TrimethoprimSun Pharmaceutical Industries, IncNDACurrent
49708-145Bactrimsulfamethoxazole and TrimethoprimSun Pharmaceutical Industries, IncNDACurrent
49708-145Bactrimsulfamethoxazole and TrimethoprimSun Pharmaceutical Industries, IncNDACurrent
49708-145Bactrimsulfamethoxazole and TrimethoprimSun Pharmaceutical Industries, IncNDACurrent
49708-146Bactrim DSsulfamethoxazole and TrimethoprimSun Pharmaceutical Industries, IncNDACurrent
49708-146Bactrim DSsulfamethoxazole and TrimethoprimSun Pharmaceutical Industries, IncNDACurrent
49708-146Bactrim DSsulfamethoxazole and TrimethoprimSun Pharmaceutical Industries, IncNDACurrent
49708-146Bactrim DSsulfamethoxazole and TrimethoprimSun Pharmaceutical Industries, IncNDACurrent
49708-146Bactrim DSsulfamethoxazole and TrimethoprimSun Pharmaceutical Industries, IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81349SUPPL 2025-02-25
81326SUPPL 2025-02-24
78892SUPPL 2024-06-25
78888SUPPL 2024-06-25
67429SUPPL2021-05-06
67388SUPPL2021-05-04
64142SUPPL2020-07-30
64118SUPPL2020-07-29
33251SUPPL2014-07-17
13119SUPPL2014-07-17
10978SUPPL2013-07-17
10977SUPPL2013-07-17
13118SUPPL2013-07-15
13117SUPPL2013-07-15
33250SUPPL2012-08-31
569SUPPL2012-08-31
33249SUPPL2010-07-31
13116SUPPL2010-07-29
13115SUPPL2010-07-02
33248SUPPL2007-06-07
568SUPPL2007-06-07
33247SUPPL2003-02-12
567SUPPL2003-02-12
13114SUPPL2002-10-17
10976SUPPL2002-10-17