Application 217468

Type: ANDA
Sponsor: NAVINTA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIAZEPAM	DIAZEPAM	GEL;RECTAL	2.5MG/0.5ML (5MG/ML)	No	No
002	DIAZEPAM	DIAZEPAM	GEL;RECTAL	10MG/2ML (5MG/ML)	No	No
003	DIAZEPAM	DIAZEPAM	GEL;RECTAL	20MG/4ML (5MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A217468-001	DIAZEPAM	DIAZEPAM	2.5MG/0.5ML (5MG/ML)	GEL / RECTAL	AB	2025-11-14
A217468-002	DIAZEPAM	DIAZEPAM	10MG/2ML (5MG/ML)	GEL / RECTAL	AB	2025-11-14
A217468-003	DIAZEPAM	DIAZEPAM	20MG/4ML (5MG/ML)	GEL / RECTAL	AB	2025-11-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A217468-001	AB
A217468-002	AB
A217468-003	AB

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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A217468-001	DIAZEPAM	2.5MG/0.5ML (5MG/ML)	GEL / RECTAL	AB	2025-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217468-002	DIAZEPAM	10MG/2ML (5MG/ML)	GEL / RECTAL	AB	2025-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217468-003	DIAZEPAM	20MG/4ML (5MG/ML)	GEL / RECTAL	AB	2025-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217468-001	DIAZEPAM	2.5MG/0.5ML (5MG/ML)	GEL / RECTAL	AB	2025-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217468-002	DIAZEPAM	10MG/2ML (5MG/ML)	GEL / RECTAL	AB	2025-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217468-003	DIAZEPAM	20MG/4ML (5MG/ML)	GEL / RECTAL	AB	2025-11-14	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217468-001	DIAZEPAM	2.5MG/0.5ML (5MG/ML)	GEL / RECTAL	AB	2025-11-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217468-002	DIAZEPAM	10MG/2ML (5MG/ML)	GEL / RECTAL	AB	2025-11-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217468-003	DIAZEPAM	20MG/4ML (5MG/ML)	GEL / RECTAL	AB	2025-11-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A217468-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217468-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217468-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217468-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217468-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217468-003	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217468-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217468-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217468-003	AB	1	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diazepam	DIAZEPAM	Navinta LLC	b5b17a28-2cab-4c0d-8f9d-7b224e4d0989	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217468 application number: ANDA217468
Diazepam	DIAZEPAM	Zydus Pharmaceuticals USA Inc.	652714c7-25c4-4d05-979d-8eee3b6f2f4d	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217468 application number: ANDA217468

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84744	ORIG	2026-01-13