Home Applications 020298 Application 020298
Type NDA
Sponsor MYLAN INSTITUTIONAL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ALOPRIM ALLOPURINOL SODIUM INJECTABLE;INJECTION EQ 500MG BASE/VIAL Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N020298-001 ALOPRIM ALLOPURINOL SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020298-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020298-001 ALOPRIM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-17 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 · 13 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 51662-1323 GLUCAG0N glucagon kit HF Acquisition Co LLC, DBA HealthFirst NDA Current 51662-1323 GLUCAG0N glucagon kit HF Acquisition Co LLC, DBA HealthFirst NDA Current 51662-1323 GLUCAG0N glucagon kit HF Acquisition Co LLC, DBA HealthFirst NDA Current 51662-1323 GLUCAG0N glucagon kit HF Acquisition Co LLC, DBA HealthFirst NDA Current 67457-187 Aloprim Allopurinol Mylan Institutional LLC NDA Current 67457-187 Aloprim Allopurinol Mylan Institutional LLC NDA Current 67457-187 Aloprim Allopurinol Mylan Institutional LLC NDA Current 67457-187 Aloprim Allopurinol Mylan Institutional LLC NDA Current 67457-187 Aloprim Allopurinol Mylan Institutional LLC NDA Current 67457-187 Aloprim Allopurinol Mylan Institutional LLC NDA Current 67457-978 Aloprim Allopurinol Mylan Institutional LLC NDA Current 67457-978 Aloprim Allopurinol Mylan Institutional LLC NDA Current 67457-978 Aloprim Allopurinol Mylan Institutional LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 79833 SUPPL 2024-10-07 70212 SUPPL 2022-02-22 70189 SUPPL 2022-02-18 65874 SUPPL 2021-01-08 65637 SUPPL 2020-12-21 64507 SUPPL 2020-09-04 64461 SUPPL 2020-09-01 12426 SUPPL 2016-04-04