Application 076020
- Type
- ANDA
- Sponsor
- INTL MEDICATION
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1MG BASE/ML | No | No |
| 002 | MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 5MG BASE/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076020-001 | MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | ||
| A076020-002 | MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 |
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.
| 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 | A076020-001 | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076020-002 | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076020-001 | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076020-002 | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076020-001 | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076020-002 | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076020-001 | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076020-002 | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076020-001 | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076020-002 | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076020-001 | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076020-002 | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076020-001 | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076020-002 | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076020-001 | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076020-002 | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076020-001 | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076020-002 | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076020-001 | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076020-002 | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076020-001 | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076020-002 | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076020-001 | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076020-002 | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076020-001 | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076020-002 | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076020-001 | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076020-002 | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076020-001 | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076020-002 | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076020-001 | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076020-002 | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076020-001 | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076020-002 | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076020-001 | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076020-002 | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076020-001 | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076020-002 | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076020-001 | MIDAZOLAM HYDROCHLORIDE | EQ 1MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076020-002 | MIDAZOLAM HYDROCHLORIDE | EQ 5MG BASE/ML | INJECTABLE / INJECTION | 2004-07-16 | 782e0a99824c… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Midazolam Hydrochloride | MIDAZOLAM HYDROCHLORIDE | American Health Packaging | fc93242b-0abf-466a-8413-8a365620ee75 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE |
| Midazolam | MIDAZOLAM HYDROCHLORIDE | Onesource Specialty Pharma Limited | 54ed43b2-bad1-4b45-e063-6294a90a793a | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | MIDAZOLAM HYDROCHLORIDE |
| Midazolam hydrochloride | MIDAZOLAM HYDROCHLORIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 8b690f5c-2923-4c34-a8f7-11af5f546b62 | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | Midazolam hydrochloride MIDAZOLAM HYDROCHLORIDE |
| Midazolam | MIDAZOLAM HYDROCHLORIDE | Cardinal Health 107, LLC | cbedf0bf-82a4-4214-96d5-01ac35e101f0 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | MIDAZOLAM HYDROCHLORIDE |
| Midazolam Hydrochloride | MIDAZOLAM HYDROCHLORIDE | Precision Dose Inc. | 9a443652-6aff-4e27-83fe-90c65fa0f3c1 | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE |
| MIDAZOLAM | MIDAZOLAM HYDROCHLORIDE | Hospira, Inc. | b95415fa-17c2-42ab-a6b0-e628d01c94ed | 2026-05-23 | Boxed warning, Warnings, Adverse reactions | MIDAZOLAM HYDROCHLORIDE |
| Midazolam | MIDAZOLAM HYDROCHLORIDE | Hospira, Inc. | 1abda8b8-48a8-4995-af86-39220d1aa240 | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | MIDAZOLAM HYDROCHLORIDE |
| Midazolam | MIDAZOLAM HYDROCHLORIDE | Hospira, Inc. | affecd4d-1f78-4bbe-5a8d-86849bbdc520 | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | MIDAZOLAM HYDROCHLORIDE |
| Midazolam Hydrochloride | MIDAZOLAM HYDROCHLORIDE | A-S Medication Solutions | b7effb82-e180-46f0-b2e8-a0d8ebc32a2a | 2026-04-14 | Boxed warning, Warnings, Adverse reactions | Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE |
| Midazolam Hydrochloride | MIDAZOLAM HYDROCHLORIDE | Jvet Pharmaceuticals LLC | a84ddd02-1f5f-4311-9dae-2a5cb4064bf3 | 2025-12-22 | Boxed warning, Warnings, Adverse reactions | Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE |
| Midazolam | MIDAZOLAM HYDROCHLORIDE | REMEDYREPACK INC. | d9305142-417d-4d8c-9a23-f9a1b6771cac | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | MIDAZOLAM HYDROCHLORIDE |
| Midazolam Hydrochloride | MIDAZOLAM HYDROCHLORIDE | Precision Dose Inc. | 557ef7bf-9341-47f9-804d-430a24982fa6 | 2025-08-06 | Boxed warning, Warnings, Adverse reactions | Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE |
| Midazolam Hydrochloride | MIDAZOLAM HYDROCHLORIDE | Henry Schein, Inc. | 9e3bd5d3-36b3-471c-b8cc-ef48645700c2 | 2025-07-16 | Boxed warning, Warnings, Adverse reactions | Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE |
| Midazolam Hydrochloride | MIDAZOLAM HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | a833c24b-6dca-44d7-a0d6-20012fa1ea77 | 2025-04-29 | Boxed warning, Warnings, Adverse reactions | Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE |
| Midazolam in Sodium Chloride | MIDAZOLAM HYDROCHLORIDE | Sagent Pharmaceuticals | c546cfd4-4f2b-4b94-aa47-995595f1a146 | 2025-03-02 | Boxed warning, Warnings, Adverse reactions | MIDAZOLAM HYDROCHLORIDE |
| Midazolam Hydrochloride | MIDAZOLAM HYDROCHLORIDE | Belcher Pharmaceuticals, LLC | cee4cdd0-58c5-4704-9fb6-d4bffb1764a8 | 2025-02-11 | Boxed warning, Warnings, Adverse reactions | Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE |
| Midazolam | MIDAZOLAM HYDROCHLORIDE | Fresenius Kabi USA, LLC | a91ce254-14a3-4cbf-8ab8-5da252aa3fdc | 2024-07-15 | Boxed warning, Warnings, Adverse reactions | MIDAZOLAM HYDROCHLORIDE |
| Midazolam | MIDAZOLAM HYDROCHLORIDE | Fresenius Kabi USA, LLC | 1cc9ba6e-fa1b-405e-9de8-720c567b2a73 | 2024-01-01 | Boxed warning, Warnings, Adverse reactions | MIDAZOLAM HYDROCHLORIDE |
| Midazolam | MIDAZOLAM HYDROCHLORIDE | Steriscience Specialties Private Limited | 473fba4b-8754-4b1d-bba9-d9c8f6d818e0 | 2023-12-13 | Boxed warning, Warnings, Adverse reactions | MIDAZOLAM HYDROCHLORIDE |
| Midazolam | MIDAZOLAM HYDROCHLORIDE | SOMERSET THERAPEUTICS, LLC | 74666098-1ca8-4c06-8fc4-5de870b1b514 | 2023-12-05 | Boxed warning, Warnings, Adverse reactions | MIDAZOLAM HYDROCHLORIDE |