Home Applications 017598 Application 017598
Type NDA
Sponsor MONARCH PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SEPTRA SULFAMETHOXAZOLE; TRIMETHOPRIM SUSPENSION;ORAL 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No 002 SEPTRA GRAPE SULFAMETHOXAZOLE; TRIMETHOPRIM SUSPENSION;ORAL 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N017598-001 SEPTRA SULFAMETHOXAZOLE; TRIMETHOPRIM 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUSPENSION / ORAL Approved before 1982 N017598-002 SEPTRA GRAPE SULFAMETHOXAZOLE; TRIMETHOPRIM 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUSPENSION / ORAL 1986-02-12
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.
Product history page 3 of 3 · 88 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N017598-001 SEPTRA 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUSPENSION / ORAL Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N017598-002 SEPTRA GRAPE 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUSPENSION / ORAL 1986-02-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N017598-001 SEPTRA 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUSPENSION / ORAL Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N017598-002 SEPTRA GRAPE 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUSPENSION / ORAL 1986-02-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N017598-001 SEPTRA 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUSPENSION / ORAL Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N017598-002 SEPTRA GRAPE 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUSPENSION / ORAL 1986-02-12 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N017598-001 SEPTRA 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUSPENSION / ORAL Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N017598-002 SEPTRA GRAPE 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUSPENSION / ORAL 1986-02-12 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 33318 SUPPL 2008-03-13 13866 SUPPL 2008-03-13 662 SUPPL 2007-09-25 11044 SUPPL 2007-09-11 13865 SUPPL 2005-08-03 11043 SUPPL 2005-08-03