FDA.reportPublic FDA data

Application 073303

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE; TRIMETHOPRIMINJECTABLE;INJECTION80MG/ML;16MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0703-9503Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimTeva Parenteral Medicines, Inc.ANDACurrent
0703-9503Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimTeva Parenteral Medicines, Inc.ANDACurrent
0703-9503Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimTeva Parenteral Medicines, Inc.ANDACurrent
0703-9503Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimTeva Parenteral Medicines, Inc.ANDACurrent
0703-9503Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimTeva Parenteral Medicines, Inc.ANDACurrent
0703-9514Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimTeva Parenteral Medicines, Inc.ANDACurrent
0703-9514Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimTeva Parenteral Medicines, Inc.ANDACurrent
0703-9514Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimTeva Parenteral Medicines, Inc.ANDACurrent
0703-9514Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimTeva Parenteral Medicines, Inc.ANDACurrent
0703-9514Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimTeva Parenteral Medicines, Inc.ANDACurrent
0703-9514Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimTeva Parenteral Medicines, Inc.ANDACurrent
0703-9514Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimTeva Parenteral Medicines, Inc.ANDACurrent
0703-9514Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimTeva Parenteral Medicines, Inc.ANDACurrent
0703-9514Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimTeva Parenteral Medicines, Inc.ANDACurrent
0703-9514Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimTeva Parenteral Medicines, Inc.ANDACurrent
0703-9526Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimTeva Parenteral Medicines, Inc.ANDACurrent
0703-9526Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimTeva Parenteral Medicines, Inc.ANDACurrent
0703-9526Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimTeva Parenteral Medicines, Inc.ANDACurrent
0703-9526Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimTeva Parenteral Medicines, Inc.ANDACurrent
0703-9526Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimTeva Parenteral Medicines, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18352SUPPL2013-04-30