Application 216564

Type: NDA
Sponsor: DEPROCO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLAVALTA	EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE	SOLUTION;INJECTION	EQ 0.017MG BASE/1.7ML (EQ 0.01MG BASE/ML);34MG/1.7ML (20MG/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N216564-001	FLAVALTA	EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE	EQ 0.017MG BASE/1.7ML (EQ 0.01MG BASE/ML);34MG/1.7ML (20MG/ML)	SOLUTION / INJECTION		RLD, RS	2026-03-19

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N216564-001	FLAVALTA	EQ 0.017MG BASE/1.7ML (EQ 0.01MG BASE/ML);34MG/1.7ML (20MG/ML)	SOLUTION / INJECTION	RLD, RS	2026-03-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216564-001	FLAVALTA	EQ 0.017MG BASE/1.7ML (EQ 0.01MG BASE/ML);34MG/1.7ML (20MG/ML)	SOLUTION / INJECTION	RLD, RS	2026-03-19	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216564-001	FLAVALTA	EQ 0.017MG BASE/1.7ML (EQ 0.01MG BASE/ML);34MG/1.7ML (20MG/ML)	SOLUTION / INJECTION	RLD, RS	2026-03-19	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flavalta	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	Septodont, Inc.	3f9f9b4f-bf6c-4b57-ac1a-98fd1a9a369d	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216564 application number: NDA216564

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85461	ORIG	2026-03-23