Application 060365

Type: ANDA
Sponsor: BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NEOMYCIN SULFATE	NEOMYCIN SULFATE	TABLET;ORAL	500MG	No	No

Orange Book products#

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A060365-001	NEOMYCIN SULFATE	NEOMYCIN SULFATE	500MG	TABLET / ORAL		Approved before 1982

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neomycin Sulfate	NEOMYCIN SULFATE	Shaanxi Shuvita Biotech Co., Ltd	573e1fe7-4d9d-0a5f-e063-6394a90a85a8	2026-07-22	Warnings	Name fallback
Neomycin Sulfate	NEOMYCIN SULFATE	REMEDYREPACK INC.	461f62b9-b9ec-43f2-aee7-0895638105b8	2026-04-24	Boxed warning, Warnings, Adverse reactions	Name fallback
Neomycin Sulfate	NEOMYCIN SULFATE	Chartwell RX, LLC	0aa6947b-4739-4b00-be93-7303a5fc687d	2026-02-27	Boxed warning, Warnings, Adverse reactions	Name fallback
Neomycin Sulfate	NEOMYCIN SULFATE	Aldermed Inc.	4978bb06-8b7c-9a44-e063-6294a90ac4cf	2026-02-12	Warnings	Name fallback
Neomycin Sulfate	NEOMYCIN SULFATE	Solaris Pharma Corporation	f430c5d9-ae82-3314-e053-2a95a90af04c	2025-10-03	Boxed warning, Warnings, Adverse reactions	Name fallback
Neomycin Sulfate	NEOMYCIN SULFATE	Teva Pharmaceuticals USA, Inc.	777dbfab-f83e-4738-ae1e-78619a9f82a7	2022-10-12	Boxed warning, Warnings, Adverse reactions	Name fallback

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings When handling this product ■ May cause skin & eye irritation; wear full PPE (gloves, goggles, respirator) ■ Avoid direct skin contact, inhalation of dust ■ Do not ingest; keep separate from food, drinks ■ Keep away from ignition sources, strong oxidizers ■ Restless/irritability may occur with improper exposure, especially for personnel without chemical handling training If pregnant/breastfeeding, consult industrial hygiene specialist before handling. Keep out of reach of children & untrained personnel. In case of accidental ingestion/skin absorption/eye contact, flush affected area with plenty of clean water and seek emergency medical help immediately.