Home Applications 076500 Application 076500
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 A076500-001 ADENOSINE ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076500-001 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 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076500-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2004-06-16 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 3 of 3 · 53 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SFERANGS COLLAGEN RECHARGING SERUM ADENOSINE NOKSIBCHO cosmetic Co., Ltd. a2270c3a-afaa-715c-e053-2a95a90a5ab3 2020-04-30 Warnings Name fallback generic name: ADENOSINE SFERANGS COLLAGEN RECHARGINGCREAM ADENOSINE NOKSIBCHO cosmetic Co., Ltd. a377f4b1-a6ab-f17e-e053-2a95a90ad56b 2020-04-30 Warnings Name fallback generic name: ADENOSINE THE SKIN HOUSE WRINKLE COLLAGEN AMPOULE ADENOSINE NOKSIBCHO cosmetic Co., Ltd. a21ebea1-abc6-c9e8-e053-2995a90a1196 2020-04-08 Warnings Name fallback generic name: ADENOSINE THE SKIN HOUSE Wrinkle SystemCream ADENOSINE NOKSIBCHO cosmetic Co., Ltd. a21fa53d-f7ae-071c-e053-2995a90adbb7 2020-03-31 Warnings Name fallback generic name: ADENOSINE THE SKIN HOUSE Wrinkle System Essence ADENOSINE NOKSIBCHO cosmetic Co., Ltd. a2211d4f-4411-18bf-e053-2995a90a4494 2020-03-31 Warnings Name fallback generic name: ADENOSINE THE SKIN HOUSE Wrinkle System EyeCream ADENOSINE NOKSIBCHO cosmetic Co., Ltd. a2220aa2-953a-7b63-e053-2a95a90a6382 2020-03-31 Warnings Name fallback generic name: ADENOSINE THE SKIN HOUSE Wrinkle Collagen Toner ADENOSINE NOKSIBCHO cosmetic Co., Ltd. a226a209-a32f-d32e-e053-2a95a90ad0b8 2020-03-31 Warnings Name fallback generic name: ADENOSINE SFERANGS COLLAGEN RECHARGING ADENOSINE NOKSIBCHO cosmetic Co., Ltd. a2275fe6-ca8f-6ffe-e053-2995a90a2136 2020-03-31 Warnings Name fallback generic name: ADENOSINE SFERANGS COLLAGEN SYNERGY AMPOULE ADENOSINE NOKSIBCHO cosmetic Co., Ltd. a22c5134-d8b1-a185-e053-2995a90ae0f0 2020-03-31 Warnings Name fallback generic name: ADENOSINE THE SKIN HOUSE Wrinkle CollagenEmulsion ADENOSINE NOKSIBCHO cosmetic Co., Ltd. a21f1539-0022-3797-e053-2a95a90a5b92 2020-03-30 Warnings Name fallback generic name: ADENOSINE Adenosine ADENOSINE Fresenius Kabi USA, LLC 6785cf30-360f-409b-a4b2-fc910728f01f 2018-12-04 Warnings, Adverse reactions Name fallback brand name: Adenosine generic name: ADENOSINE Adenosine ADENOSINE Gland Pharma Limited 1b701a86-3c4e-4c13-bf9e-aa9e73774c20 2018-02-20 Warnings, Adverse reactions Name fallback brand name: Adenosine generic name: ADENOSINE Adenosine ADENOSINE Gland Pharma Limited ab2edabd-e57d-4754-9822-93bd17af9e88 2017-12-04 Warnings, Adverse reactions Name fallback brand name: Adenosine 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 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0641-6113 Adenosine Adenosine West-ward Pharmaceutical Corp. ANDA Current 0641-6113 Adenosine Adenosine Hikma Pharmaceuticals USA Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 22564 ORIG 2005-07-22 31131 ORIG 2004-06-16