Home Applications 065006 Application 065006
Type ANDA
Sponsor AKORN INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE SOLUTION/DROPS;OPHTHALMIC 10,000 UNITS/ML;EQ 1MG BASE/ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065006-001 TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10,000 UNITS/ML;EQ 1MG BASE/ML SOLUTION/DROPS / OPHTHALMIC AT 1998-12-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065006-001 AT
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 2 of 2 · 44 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 A065006-001 TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE 10,000 UNITS/ML;EQ 1MG BASE/ML SOLUTION/DROPS / OPHTHALMIC AT 1998-12-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065006-001 TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE 10,000 UNITS/ML;EQ 1MG BASE/ML SOLUTION/DROPS / OPHTHALMIC AT 1998-12-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065006-001 TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE 10,000 UNITS/ML;EQ 1MG BASE/ML SOLUTION/DROPS / OPHTHALMIC AT 1998-12-17 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A065006-001 TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE 10,000 UNITS/ML;EQ 1MG BASE/ML SOLUTION/DROPS / OPHTHALMIC AT 1998-12-17 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 15 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 17478-703 Trimethoprim sulfate and Polymyxin B sulfate Trimethoprim sulfate and Polymyxin B sulfate Akorn, Inc. ANDA Current 17478-703 POLYMYXIN B SULFATE AND TRIMETHOPRIM polymyxin b sulfate and trimethoprim Akorn ANDA Current 17478-703 POLYMYXIN B SULFATE AND TRIMETHOPRIM polymyxin b sulfate and trimethoprim Akorn ANDA Current 17478-703 POLYMYXIN B SULFATE AND TRIMETHOPRIM polymyxin b sulfate and trimethoprim Akorn, Inc. ANDA Current 17478-703 POLYMYXIN B SULFATE AND TRIMETHOPRIM polymyxin b sulfate and trimethoprim Akorn ANDA Current 17478-703 POLYMYXIN B SULFATE AND TRIMETHOPRIM polymyxin b sulfate and trimethoprim Akorn, Inc. ANDA Current 55700-414 Trimethoprim sulfate and Polymyxin B sulfate Trimethoprim sulfate and Polymyxin B sulfate Lake Erie Medical DBA Quality Care Products LLC ANDA Current 63187-193 Trimethoprim sulfate and Polymyxin B sulfate Trimethoprim sulfate and Polymyxin B sulfate Proficient Rx LP ANDA Current 63187-193 Trimethoprim sulfate and Polymyxin B sulfate Trimethoprim sulfate and Polymyxin B sulfate Proficient Rx LP ANDA Current 68788-0536 Trimethoprim sulfate and Polymyxin B sulfate Trimethoprim sulfate and Polymyxin B sulfate Preferred Pharmaceuticals Inc. ANDA Current 68788-0536 Trimethoprim sulfate and Polymyxin B sulfate Trimethoprim sulfate and Polymyxin B sulfate Preferred Pharmaceuticals Inc. ANDA Current 68788-0536 Trimethoprim sulfate and Polymyxin B sulfate Trimethoprim sulfate and Polymyxin B sulfate Preferred Pharmaceuticals ANDA Current 70518-1194 Trimethoprim sulfate and Polymyxin B sulfate Trimethoprim sulfate and Polymyxin B sulfate REMEDYREPACK INC. ANDA Current 70518-1194 Trimethoprim sulfate and Polymyxin B sulfate Trimethoprim sulfate and Polymyxin B sulfate REMEDYREPACK INC. ANDA Current 72189-005 POLYMYXIN B SULFATE AND TRIMETHOPRIM POLYMYXIN B SULFATE AND TRIMETHOPRIM Direct_Rx ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 30623 ORIG 1998-12-17