Home Applications 062166 Application 062166
Type ANDA
Sponsor PERRIGO CO TENNESSEE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 002 BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE BACITRACIN ZINC; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE OINTMENT;OPHTHALMIC 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM No 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 A062166-002 BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE BACITRACIN ZINC; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400 UNITS/GM;1%;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 A062166-002 BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT / OPHTHALMIC RS, Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A062166-002 BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT / OPHTHALMIC RS, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A062166-002 BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT / OPHTHALMIC RS, Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A062166-002 BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT / OPHTHALMIC Approved before 1982 a50c72e98297…
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 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0574-4144 Neo Polycin HC neomycin and polymyxin b sulfates, bacitracin zinc and hydrocortisone acetate Paddock Laboratories, LLC ANDA Current 0574-4144 Neo Polycin HC neomycin and polymyxin b sulfates, bacitracin zinc and hydrocortisone acetate Padagis US LLC ANDA Current 21695-736 Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate Neomycin sulfate and Polymyxin B Sulfate, Bacitracin zinc and Hydrocortisone Acetate Rebel Distributors Corp ANDA Current