Application 062008

Type: ANDA
Sponsor: LILLY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NEBCIN	TOBRAMYCIN SULFATE	INJECTABLE;INJECTION	EQ 40MG BASE/ML	No	No
004	NEBCIN	TOBRAMYCIN SULFATE	INJECTABLE;INJECTION	EQ 10MG BASE/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A062008-001	NEBCIN	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION		Approved before 1982
A062008-004	NEBCIN	TOBRAMYCIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A062008-001	NEBCIN	EQ 40MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A062008-004	NEBCIN	EQ 10MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062008-001	NEBCIN	EQ 40MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A062008-004	NEBCIN	EQ 10MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062008-001	NEBCIN	EQ 40MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062008-004	NEBCIN	EQ 10MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A062008-001	NEBCIN	EQ 40MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A062008-004	NEBCIN	EQ 10MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`a50c72e98297…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tobramycin	TOBRAMYCIN SULFATE	Fresenius Kabi USA, LLC	9a5cecd6-aa65-42d2-b15a-06b4fcebcc0f	2024-02-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOBRAMYCIN SULFATE
Tobramycin	TOBRAMYCIN SULFATE	Fresenius Kabi USA, LLC	d6dd9460-b030-479a-b3e3-03606e6fcad1	2024-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOBRAMYCIN SULFATE
Tobramycin	TOBRAMYCIN SULFATE	Fresenius Kabi USA, LLC	d62ff359-912b-4be1-9fc2-2dde8777eefb	2024-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOBRAMYCIN SULFATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.