Application 076501

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ADENOSINE	ADENOSINE	INJECTABLE;INJECTION	3MG/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
A076501-001	ADENOSINE	ADENOSINE	3MG/ML	INJECTABLE / INJECTION			2004-06-16

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 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076501-001	ADENOSINE	3MG/ML	INJECTABLE / INJECTION	2004-06-16	`f41ea6bd6efb…`

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 2 of 3 · 53 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Adenosine	ADENOSINE	Fresenius Kabi USA, LLC	e660f71c-35ed-438e-8505-4538f5e925a2	2023-04-01	Warnings, Adverse reactions	Name fallback brand name: Adenosine generic name: ADENOSINE
Adenosine	ADENOSINE	Fresenius Kabi USA, LLC	f88a8cf7-d354-42f2-b5e8-ba002fcfc460	2023-03-02	Warnings, Adverse reactions	Name fallback brand name: Adenosine generic name: ADENOSINE
Tenue 24k gold ampoule	ADENOSINE	LAON COMMERCE co ltd	e900ae7a-44ee-fea9-e053-2995a90a5477	2022-09-18	Warnings	Name fallback generic name: ADENOSINE
Adenosine	ADENOSINE	Mylan Institutional LLC	23e5c868-944f-4cc8-887f-9a2dc811af92	2022-07-01	Warnings, Adverse reactions	Name fallback brand name: Adenosine generic name: ADENOSINE
adenosine	ADENOSINE	Mylan Institutional LLC	c1c149fe-9095-4b2a-a21f-7af3212e0254	2022-04-06	Warnings, Adverse reactions	Name fallback brand name: adenosine generic name: ADENOSINE
YOMA AMPOULE PLUS ALOE MASK PACK	ADENOSINE	LAON COMMERCE co ltd	d4414ffb-740a-58a2-e053-2a95a90ae149	2021-12-28	Warnings	Name fallback generic name: ADENOSINE
YOMA AMPOULE PLUS SNAIL MASK PACK	ADENOSINE	LAON COMMERCE co ltd	d441c886-21e8-7d9e-e053-2a95a90ab434	2021-12-28	Warnings	Name fallback generic name: ADENOSINE
YOMA AMPOULE PLUS GINSENG MASK PACK	ADENOSINE	LAON COMMERCE co ltd	d441c886-21e9-7d9e-e053-2a95a90ab434	2021-12-28	Warnings	Name fallback generic name: ADENOSINE
YOMA AMPOULE PLUS COLLAGEN MASK PACK	ADENOSINE	LAON COMMERCE co ltd	d4421ee8-977b-7d5b-e053-2995a90a6aa7	2021-12-28	Warnings	Name fallback generic name: ADENOSINE
THE SKINHOUSE BLACK SNAIL WRINKLE	ADENOSINE	NOKSIBCHO cosmetic Co., Ltd.	64550035-9765-4a1e-8d9e-bb1dd7773637	2021-07-15	Warnings	Name fallback generic name: ADENOSINE
THE SKINHOUSE WRINKLE COLLAGEN	ADENOSINE	NOKSIBCHO cosmetic Co., Ltd.	f0c66bd1-77dd-4d0f-aa2b-32c2842ff95a	2021-07-15	Warnings	Name fallback generic name: ADENOSINE
THE SKINHOUSE GREEN TEA COLLAGEN	ADENOSINE	NOKSIBCHO cosmetic Co., Ltd.	fec9f9be-c359-4817-94e0-fbd7bf600958	2021-07-15	Warnings	Name fallback generic name: ADENOSINE
THE SKINHOUSE WRINKLE EYE PLUS	ADENOSINE	NOKSIBCHO cosmetic Co., Ltd.	4a783d31-f765-4e41-b9aa-e391bab2ed74	2021-07-15	Warnings	Name fallback generic name: ADENOSINE
THE SKINHOUSE WRINKLE COLLAGEN FREE SPOT	ADENOSINE	NOKSIBCHO cosmetic Co., Ltd.	cd591754-0228-4b6d-9107-1210abdb7e23	2021-07-15	Warnings	Name fallback generic name: ADENOSINE
THE SKINHOUSE REAL SNAIL WRINKLE FREE	ADENOSINE	NOKSIBCHO cosmetic Co., Ltd.	6276f488-716e-41dd-a811-3d315be9b60c	2021-07-15	Warnings	Name fallback generic name: ADENOSINE
adenosine	ADENOSINE	Mylan Institutional LLC	d2d06ee6-c89f-49f7-9e2c-46d33ce877a9	2021-06-16	Warnings, Adverse reactions	Name fallback brand name: adenosine generic name: ADENOSINE
ADENOSINE	ADENOSINE	HF Acquisition Co LLC, DBA HealthFirst	b973bce7-0500-63a2-e053-2a95a90af9e2	2021-01-22	Warnings, Adverse reactions	Name fallback brand name: ADENOSINE generic name: ADENOSINE
MULTI FUNCTION SLEEPING PACK	ADENOSINE	NOKSIBCHO cosmetic Co., Ltd.	aeb32944-fbf5-64ab-e053-2a95a90a58c2	2020-09-07	Warnings	Name fallback generic name: ADENOSINE
THE SKIN HOUSE Wrinkle Snail SystemCream	ADENOSINE	NOKSIBCHO cosmetic Co., Ltd.	a21f02ef-6251-139b-e053-2995a90aa0b3	2020-05-13	Warnings	Name fallback generic name: ADENOSINE
SFERANGS COLLAGEN RECHARGING TONER	ADENOSINE	NOKSIBCHO cosmetic Co., Ltd.	a22c41d5-21a1-7d78-e053-2995a90a2f92	2020-04-30	Warnings	Name fallback generic name: ADENOSINE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10019-063	Adenosine	ADENOSINE	Baxter Healthcare Corpora	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43082	ORIG	2005-07-22
31132	ORIG	2004-06-16