Home Applications 065213 Application 065213
Type ANDA
Sponsor AKORN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE OINTMENT;OPHTHALMIC 400 UNITS/GM;1%;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 A065213-001 NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT / OPHTHALMIC 2012-07-25
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 A065213-001 NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT / OPHTHALMIC AT 2012-07-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065213-001 NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT / OPHTHALMIC AT 2012-07-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065213-001 NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT / OPHTHALMIC AT 2012-07-25 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A065213-001 NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT / OPHTHALMIC 2012-07-25 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 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0404-7195 Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone Henry Schein Inc. ANDA Current 0404-7195 Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone Henry Schein Inc. ANDA Current 0404-7195 Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone Henry Schein Inc. ANDA Current 13985-608 Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone MWI ANDA Current 13985-608 Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone MWI ANDA Current 13985-608 Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone MWI ANDA Current 17478-719 Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc, Hydrocortisone Akorn, Inc. ANDA Current 17478-719 Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc, Hydrocortisone Akorn ANDA Current 17478-719 Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc, Hydrocortisone Akorn, Inc. ANDA Current