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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A073303-001SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE; TRIMETHOPRIM80MG/ML;16MG/MLINJECTABLE / INJECTIONAP1991-10-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A073303-001AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A073303-001SULFAMETHOXAZOLE AND TRIMETHOPRIM80MG/ML;16MG/MLINJECTABLE / INJECTIONAP1991-10-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A073303-001AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMTeva Parenteral Medicines, Inc.bf7a0845-de4f-46be-841a-0faf47f8b5302025-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073303
application number: ANDA073303
ndc (product): 0703-9514
ndc (product): 0703-9526
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMTeva Parenteral Medicines, Inc.b89b5502-ce87-45a6-a43c-9891da3cfca42025-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073303
application number: ANDA073303
ndc (product): 0703-9514
ndc (product): 0703-9526
ndc (product): 0703-9503
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMTeva Parenteral Medicines, Inc.640f5b0c-748d-4a68-a1de-59cc3e00ed492025-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073303
application number: ANDA073303
ndc (product): 0703-9514

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

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