Application 217178

Type: ANDA
Sponsor: LONG GROVE PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIAZEPAM	DIAZEPAM	INJECTABLE;INJECTION	10MG/2ML (5MG/ML)	No	No

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
A217178-001	DIAZEPAM	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		2024-12-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217178-001	AP

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
2026-09-14 22:38:34	2026-08	A217178-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-12-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217178-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-12-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217178-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-12-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217178-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-12-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217178-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-12-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217178-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-12-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217178-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-12-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217178-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-12-31	`03ed91905a0d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217178-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-12-31	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A217178-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217178-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217178-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217178-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217178-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217178-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217178-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217178-001	AP	1	`03ed91905a0d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217178-001	AP	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 3 of 5 · 89 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diazepam	DIAZEPAM	A-S Medication Solutions	ec433be5-d84d-425f-9edf-71263f885eec	2025-08-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Precision Dose Inc.	78d5a77d-5ca7-4f16-b4d0-fce86456593c	2025-08-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Fresenius Kabi USA, LLC	ae52866a-0b9a-4baf-af1b-f9d5e00c0e56	2025-08-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Mylan Institutional Inc.	b326c66d-5762-4d16-933c-619fa2088ccd	2025-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	A-S Medication Solutions	b47dc708-e83b-4224-bdb5-c9b7abd35cfb	2025-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Natco Pharma USA LLC	a14f5930-a3ac-4996-9778-df5baa3d0bab	2025-04-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
DIAZEPAM	DIAZEPAM	Advanced Rx of Tennessee, LLC	32c3af91-a57a-1278-e063-6294a90ae5ec	2025-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DIAZEPAM generic name: DIAZEPAM
Diazepam	DIAZEPAM	Advanced Rx of Tennessee, LLC	2d322c6a-7f7e-1cc4-e063-6294a90a8e2e	2025-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Civica, Inc.	83646a0f-eb43-4871-b95e-683c2533d2be	2025-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Asclemed USA, Inc.	32e7bfa1-6060-4041-a0e5-249cacb84ebc	2025-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
DIAZEPAM	DIAZEPAM	Proficient Rx LP	9322b0bc-e9fa-4c89-808b-110decf6db58	2025-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DIAZEPAM generic name: DIAZEPAM
Diazepam	DIAZEPAM	Advanced Rx Pharmacy of Tennessee, LLC	b7002d26-3856-4c2f-e053-2995a90aea60	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
DIAZEPAM	DIAZEPAM	NuCare Pharmaceuticals, Inc.	21785bb2-cc96-7973-e063-6294a90ab1b8	2024-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DIAZEPAM generic name: DIAZEPAM
DIAZEPAM	DIAZEPAM	Sunrise Pharmaceutical, Inc.	34ac0b9d-d4ad-4aaa-8bee-902365f4e9a8	2024-12-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DIAZEPAM generic name: DIAZEPAM
Diazepam	DIAZEPAM	Hikma Pharmaceuticals USA Inc.	9e85abed-1a8b-4762-a31f-f2c7f196b8af	2024-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
DIAZEPAM	DIAZEPAM	NuCare Pharmaceuticals, Inc	22688087-27ad-620c-e063-6394a90a134c	2024-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DIAZEPAM generic name: DIAZEPAM
Diazepam	DIAZEPAM	Bryant Ranch Prepack	9424ce71-f04c-4d70-89de-b7858931c53d	2024-08-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Bryant Ranch Prepack	632d7e96-d32c-45b8-86cf-f18ec2b35485	2024-08-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	Direct_rx	2047f721-6a05-c391-e063-6394a90a4ed7	2024-08-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM
Diazepam	DIAZEPAM	NuCare Pharmaceuticals,Inc.	823093aa-d0cd-53c9-e053-2a91aa0a5235	2024-06-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diazepam generic name: DIAZEPAM

Reported adverse events (FAERS/openFDA)#

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