Home Applications 040784 Application 040784
Type ANDA
Sponsor XGEN PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ACETAZOLAMIDE SODIUM ACETAZOLAMIDE SODIUM INJECTABLE;INJECTION EQ 500MG BASE/VIAL No 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 A040784-001 ACETAZOLAMIDE SODIUM ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040784-001 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 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040784-001 ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2008-12-10 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 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 39822-0190 Acetazolamide Acetazolamide XGen Pharmaceuticals DJB, Inc. ANDA Current 39822-0190 Acetazolamide Acetazolamide X-GEN Pharmaceuticals, Inc. ANDA Current 39822-0190 Acetazolamide Acetazolamide XGen Pharmaceuticals DJB, Inc. ANDA Current 39822-0190 Acetazolamide Acetazolamide X-GEN Pharmaceuticals, Inc. ANDA Current 39822-0190 Acetazolamide Acetazolamide X-GEN Pharmaceuticals, Inc. ANDA Current 39822-0190 Acetazolamide Acetazolamide X-GEN Pharmaceuticals, Inc. ANDA Current 39822-0191 Acetazolamide Acetazolamide X-GEN Pharmaceuticals, Inc. ANDA Current