Home Applications 060764 Application 060764
Type ANDA
Sponsor PERRIGO CO TENNESSEE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 002 NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE OINTMENT;OPHTHALMIC 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM 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 A060764-002 NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT / OPHTHALMIC Approved before 1982
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 A060764-002 NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT / OPHTHALMIC AT Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A060764-002 NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT / OPHTHALMIC AT Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A060764-002 NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT / OPHTHALMIC AT Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A060764-002 NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT / OPHTHALMIC Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0574-4250 Neo Polycin neomycin and polymyxin B sulfates and bacitracin zinc Padagis US LLC ANDA Current 0574-4250 Neo Polycin neomycin and polymyxin B sulfates and bacitracin zinc Paddock Laboratories, LLC ANDA Current 0574-4250 Neo Polycin neomycin and polymyxin B sulfates and bacitracin zinc Paddock Laboratories, LLC ANDA Current 26637-841 Neomycin and polymyxin B sulfates and bacitracin zinc neomycin sulfate, polymyxin B sulfate, bacitracin zinc Putney, Inc. ANDA Current 42254-302 NEO-POLYCIN NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC Rebel Distributors Corp ANDA Current 50090-2240 Neo Polycin neomycin and polymyxin B sulfates and bacitracin zinc A-S Medication Solutions ANDA Current