Home Applications 205331 Application 205331
Type ANDA
Sponsor AUROBINDO PHARMA LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ADENOSINE ADENOSINE SOLUTION;INTRAVENOUS 60MG/20ML (3MG/ML) No No 002 ADENOSINE ADENOSINE SOLUTION;INTRAVENOUS 90MG/30ML (3MG/ML) No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205331-001 ADENOSINE ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 A205331-002 ADENOSINE ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 84 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 2026-08-18 06:07:40 2026-07 A205331-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205331-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205331-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205331-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205331-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205331-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205331-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205331-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205331-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205331-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205331-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205331-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205331-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205331-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205331-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205331-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205331-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205331-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205331-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205331-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205331-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205331-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205331-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205331-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205331-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205331-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205331-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205331-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205331-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205331-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205331-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205331-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205331-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A205331-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205331-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A205331-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205331-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A205331-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205331-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A205331-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-02 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 55150-192 Adenosine Adenosine AuroMedics Pharma LLC ANDA Current 55150-192 Adenosine Adenosine AuroMedics Pharma LLC ANDA Current 55150-192 Adenosine Adenosine AuroMedics Pharma LLC ANDA Current 55150-192 Adenosine Adenosine AuroMedics Pharma LLC ANDA Current 55150-193 Adenosine Adenosine AuroMedics Pharma LLC ANDA Current 55150-193 Adenosine Adenosine AuroMedics Pharma LLC ANDA Current 55150-193 Adenosine Adenosine AuroMedics Pharma LLC ANDA Current 55150-193 Adenosine Adenosine AuroMedics Pharma LLC ANDA Current