Home Applications 078076 Application 078076
Type ANDA
Sponsor AKORN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ADENOSINE ADENOSINE INJECTABLE;INJECTION 3MG/ML No 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 A078076-001 ADENOSINE ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078076-001 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.
Product history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078076-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP RS 2008-10-31 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 · 27 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0404-9809 Adenosine Adenosine Henry Schein, Inc. ANDA Current 0404-9809 Adenosine Adenosine Henry Schein, Inc. ANDA Current 17478-542 Adenosine Adenosine Akorn, Inc. ANDA Current 17478-542 Adenosine Adenosine Akorn ANDA Current 17478-542 Adenosine Adenosine Akorn ANDA Current 17478-542 Adenosine Adenosine Akorn ANDA Current 17478-542 Adenosine Adenosine Akorn, Inc. ANDA Current 17478-542 Adenosine Adenosine Akorn, Inc. ANDA Current 17478-542 Adenosine Adenosine Akorn, Inc. ANDA Current 17478-953 Adenosine Adenosine Akorn, Inc. ANDA Current 17478-953 Adenosine Adenosine Akorn ANDA Current 17478-953 Adenosine Adenosine Akorn ANDA Current 17478-953 Adenosine Adenosine Akorn, Inc. ANDA Current 17478-953 Adenosine Adenosine Akorn, Inc. ANDA Current 50090-1548 Adenosine Adenosine A-S Medication Solutions ANDA Current 51662-1201 Adenosine Injection, 6mg/2mL (3mg/mL) Vial Adenosine Injection, 6mg/2mL (3mg/mL) Vial HF Acquisition Co. LLC, DBA Health First ANDA Current 51662-1201 Adenosine Injection, 6mg/2mL (3mg/mL) Vial Adenosine Injection, 6mg/2mL (3mg/mL) Vial HF Acquisition Co. LLC, DBA Health First ANDA Current 51662-1201 Adenosine Injection, 6mg/2mL (3mg/mL) Vial Adenosine Injection, 6mg/2mL (3mg/mL) Vial HF Acquisition Co. LLC, DBA Health First ANDA Current 51662-1201 Adenosine Injection, 6mg/2mL (3mg/mL) Vial Adenosine Injection, 6mg/2mL (3mg/mL) Vial HF Acquisition Co. LLC, DBA Health First ANDA Current 52584-026 Adenosine Adenosine General Injectables & Vaccines, Inc ANDA Current 52584-026 Adenosine Adenosine General Injectables & Vaccines, Inc ANDA Current 52584-026 Adenosine Adenosine General Injectables & Vaccines, Inc ANDA Current 52584-026 Adenosine Adenosine General Injectables & Vaccines, Inc ANDA Current 55154-1279 Adenosine adenosine Cardinal Health ANDA Current 71872-7035 Adenosine Adenosine Medical Purchasing Solutions, LLC ANDA Current 71872-7035 Adenosine Adenosine Medical Purchasing Solutions, LLC ANDA Current 71872-7099 Adenosine Adenosine Medical Purchasing Solutions, LLC ANDA Current