Home Applications 076150 Application 076150
Type ANDA
Sponsor INTL MEDICATION SYS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LORAZEPAM LORAZEPAM INJECTABLE;INJECTION 2MG/ML No No
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 A076150-001 LORAZEPAM LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076150-001 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 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lorazepam LORAZEPAM International Medication Systems, Limited 7dda070d-7809-46c4-8592-eb4e4c509707 2024-03-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076150 application number: ANDA076150 ndc (product): 76329-8261
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 70518-3225 Lorazepam Lorazepam REMEDYREPACK INC. ANDA Current 70518-3225 Lorazepam Lorazepam REMEDYREPACK INC. ANDA Current 70518-3225 Lorazepam Lorazepam REMEDYREPACK INC. ANDA Current 76329-8261 Lorazepam Lorazepam International Medication Systems, Limited ANDA Current 76329-8261 Lorazepam Lorazepam International Medication Systems, Limited ANDA Current 76329-8261 Lorazepam Lorazepam International Medication Systems, Limited ANDA Current 76329-8261 Lorazepam Lorazepam International Medication Systems, Limited ANDA Current