Home Applications 050567 Application 050567
Type NDA
Sponsor ALLERGAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 POLYTRIM POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE SOLUTION/DROPS;OPHTHALMIC 10,000 UNITS/ML;EQ 1MG BASE/ML Yes Yes
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 N050567-001 POLYTRIM POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10,000 UNITS/ML;EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION/DROPS / OPHTHALMIC RLD 1988-10-20
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 N050567-001 POLYTRIM 10,000 UNITS/ML;EQ 1MG BASE/ML SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1988-10-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050567-001 POLYTRIM 10,000 UNITS/ML;EQ 1MG BASE/ML SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1988-10-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050567-001 POLYTRIM 10,000 UNITS/ML;EQ 1MG BASE/ML SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1988-10-20 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050567-001 POLYTRIM 10,000 UNITS/ML;EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION/DROPS / OPHTHALMIC RLD 1988-10-20 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 17 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0023-7824 Polytrim polymyxin b sulfate and trimethoprim sulfate Allergan, Inc. NDA Current 0023-7824 Polytrim polymyxin b sulfate and trimethoprim sulfate Allergan, Inc. NDA Current 0023-7824 Polytrim polymyxin b sulfate and trimethoprim sulfate Allergan, Inc. NDA Current 50090-1540 Polytrim polymyxin b sulfate and trimethoprim sulfate A-S Medication Solutions NDA Current 50090-2064 POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE polymyxin B sulfate, trimethoprim sulfate A-S Medication Solutions NDA AUTHORIZED GENERIC Current 52959-609 POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE polymyxin B sulfate, trimethoprim sulfate H.J. Harkins Company, Inc. NDA AUTHORIZED GENERIC Current 55700-105 POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE polymyxin B sulfate, trimethoprim sulfate Quality Care Products LLC NDA AUTHORIZED GENERIC Current 55700-105 POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE polymyxin B sulfate, trimethoprim sulfate Quality Care Products LLC NDA AUTHORIZED GENERIC Current 55700-105 POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE polymyxin B sulfate, trimethoprim sulfate Quality Care Products LLC NDA AUTHORIZED GENERIC Current 55700-105 POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE polymyxin B sulfate, trimethoprim sulfate Lake Erie Medical DBA Quality Care Products LLC NDA AUTHORIZED GENERIC Current 60758-908 POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE polymyxin B sulfate, trimethoprim sulfate Pacific Pharma, Inc. NDA AUTHORIZED GENERIC Current 60758-908 POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE polymyxin B sulfate, trimethoprim sulfate Pacific Pharma, Inc. NDA AUTHORIZED GENERIC Current 61919-233 POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE DIRECT RX NDA AUTHORIZED GENERIC Current 61919-233 POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE DIRECT RX NDA AUTHORIZED GENERIC Current 61919-233 POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE DIRECT RX NDA AUTHORIZED GENERIC Current 70518-3206 POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE polymyxin B sulfate, trimethoprim sulfate REMEDYREPACK INC. NDA AUTHORIZED GENERIC Current 70518-3206 POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE polymyxin B sulfate, trimethoprim sulfate REMEDYREPACK INC. NDA AUTHORIZED GENERIC Current
Documents# Document, Submission type, Date table Document Submission type Date 83287 SUPPL 2025-09-05 83041 SUPPL 2025-08-05