Home Applications 075154 Application 075154
Type ANDA
Sponsor FRESENIUS KABI USA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 5MG BASE/ML No No 002 MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/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 A075154-001 MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 A075154-002 MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20
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 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 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 · 25 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0404-9912 Midazolam Midazolam Henry Schein, Inc. ANDA Current 0404-9912 Midazolam Midazolam Henry Schein, Inc. ANDA Current 52584-081 Midazolam Midazolam General Injectables and Vaccines, Inc. ANDA Current 52584-081 Midazolam Midazolam General Injectables and Vaccines, Inc. ANDA Current 52584-081 Midazolam Midazolam General Injectables and Vaccines, Inc. ANDA Current 63323-411 Midazolam MIDAZOLAM HYDROCHLORIDE Fresenius Kabi USA, LLC ANDA Current 63323-411 Midazolam MIDAZOLAM HYDROCHLORIDE Fresenius Kabi USA, LLC ANDA Current 63323-411 Midazolam MIDAZOLAM HYDROCHLORIDE Fresenius Kabi USA, LLC ANDA Current 63323-412 Midazolam MIDAZOLAM HYDROCHLORIDE Fresenius Kabi USA, LLC ANDA Current 63323-412 Midazolam MIDAZOLAM HYDROCHLORIDE Fresenius Kabi USA, LLC ANDA Current 63323-412 Midazolam MIDAZOLAM HYDROCHLORIDE Fresenius Kabi USA, LLC ANDA Current 65293-411 Midazolam MIDAZOLAM HYDROCHLORIDE The Medicines Company ANDA Current 65293-411 Midazolam MIDAZOLAM HYDROCHLORIDE The Medicines Company ANDA Current 65293-412 Midazolam MIDAZOLAM HYDROCHLORIDE The Medicines Company ANDA Current 65293-412 Midazolam MIDAZOLAM HYDROCHLORIDE The Medicines Company ANDA Current 65293-413 Midazolam MIDAZOLAM HYDROCHLORIDE The Medicines Company ANDA Current 65293-413 Midazolam MIDAZOLAM HYDROCHLORIDE The Medicines Company ANDA Current 65293-414 Midazolam MIDAZOLAM HYDROCHLORIDE The Medicines Company ANDA Current 65293-414 Midazolam MIDAZOLAM HYDROCHLORIDE The Medicines Company ANDA Current 65293-415 Midazolam MIDAZOLAM HYDROCHLORIDE The Medicines Company ANDA Current 65293-415 Midazolam MIDAZOLAM HYDROCHLORIDE The Medicines Company ANDA Current 65293-416 Midazolam MIDAZOLAM HYDROCHLORIDE The Medicines Company ANDA Current 65293-416 Midazolam MIDAZOLAM HYDROCHLORIDE The Medicines Company ANDA Current 65293-417 Midazolam MIDAZOLAM HYDROCHLORIDE The Medicines Company ANDA Current 65293-417 Midazolam MIDAZOLAM HYDROCHLORIDE The Medicines Company ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 8541 ORIG 2004-06-09 30776 ORIG 2000-06-20