Application 050632
- Type
- NDA
- Sponsor
- BRISTOL MYERS SQUIBB
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AZACTAM IN PLASTIC CONTAINER | AZTREONAM | INJECTABLE;INJECTION | 40MG/ML | Yes | No |
| 002 | AZACTAM IN PLASTIC CONTAINER | AZTREONAM | INJECTABLE;INJECTION | 20MG/ML | Yes | No |
| 003 | AZACTAM IN PLASTIC CONTAINER | AZTREONAM | INJECTABLE;INJECTION | 10MG/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050632-001 | AZACTAM IN PLASTIC CONTAINER | AZTREONAM | 40MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | |
| N050632-002 | AZACTAM IN PLASTIC CONTAINER | AZTREONAM | 20MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | |
| N050632-003 | AZACTAM IN PLASTIC CONTAINER | AZTREONAM | 10MG/ML | INJECTABLE / INJECTION | 1989-05-24 |
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 | N050632-001 | AZACTAM IN PLASTIC CONTAINER | 40MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050632-002 | AZACTAM IN PLASTIC CONTAINER | 20MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050632-003 | AZACTAM IN PLASTIC CONTAINER | 10MG/ML | INJECTABLE / INJECTION | 1989-05-24 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050632-001 | AZACTAM IN PLASTIC CONTAINER | 40MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050632-002 | AZACTAM IN PLASTIC CONTAINER | 20MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050632-003 | AZACTAM IN PLASTIC CONTAINER | 10MG/ML | INJECTABLE / INJECTION | 1989-05-24 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050632-001 | AZACTAM IN PLASTIC CONTAINER | 40MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050632-002 | AZACTAM IN PLASTIC CONTAINER | 20MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050632-003 | AZACTAM IN PLASTIC CONTAINER | 10MG/ML | INJECTABLE / INJECTION | 1989-05-24 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050632-001 | AZACTAM IN PLASTIC CONTAINER | 40MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050632-002 | AZACTAM IN PLASTIC CONTAINER | 20MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050632-003 | AZACTAM IN PLASTIC CONTAINER | 10MG/ML | INJECTABLE / INJECTION | 1989-05-24 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050632-001 | AZACTAM IN PLASTIC CONTAINER | 40MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050632-002 | AZACTAM IN PLASTIC CONTAINER | 20MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050632-003 | AZACTAM IN PLASTIC CONTAINER | 10MG/ML | INJECTABLE / INJECTION | 1989-05-24 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050632-001 | AZACTAM IN PLASTIC CONTAINER | 40MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050632-002 | AZACTAM IN PLASTIC CONTAINER | 20MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050632-003 | AZACTAM IN PLASTIC CONTAINER | 10MG/ML | INJECTABLE / INJECTION | 1989-05-24 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050632-001 | AZACTAM IN PLASTIC CONTAINER | 40MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050632-002 | AZACTAM IN PLASTIC CONTAINER | 20MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050632-003 | AZACTAM IN PLASTIC CONTAINER | 10MG/ML | INJECTABLE / INJECTION | 1989-05-24 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050632-001 | AZACTAM IN PLASTIC CONTAINER | 40MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050632-002 | AZACTAM IN PLASTIC CONTAINER | 20MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050632-003 | AZACTAM IN PLASTIC CONTAINER | 10MG/ML | INJECTABLE / INJECTION | 1989-05-24 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050632-001 | AZACTAM IN PLASTIC CONTAINER | 40MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050632-002 | AZACTAM IN PLASTIC CONTAINER | 20MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050632-003 | AZACTAM IN PLASTIC CONTAINER | 10MG/ML | INJECTABLE / INJECTION | 1989-05-24 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N050632-001 | AZACTAM IN PLASTIC CONTAINER | 40MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050632-002 | AZACTAM IN PLASTIC CONTAINER | 20MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050632-003 | AZACTAM IN PLASTIC CONTAINER | 10MG/ML | INJECTABLE / INJECTION | 1989-05-24 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050632-001 | AZACTAM IN PLASTIC CONTAINER | 40MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050632-002 | AZACTAM IN PLASTIC CONTAINER | 20MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050632-003 | AZACTAM IN PLASTIC CONTAINER | 10MG/ML | INJECTABLE / INJECTION | 1989-05-24 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050632-001 | AZACTAM IN PLASTIC CONTAINER | 40MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050632-002 | AZACTAM IN PLASTIC CONTAINER | 20MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050632-003 | AZACTAM IN PLASTIC CONTAINER | 10MG/ML | INJECTABLE / INJECTION | 1989-05-24 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050632-001 | AZACTAM IN PLASTIC CONTAINER | 40MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050632-002 | AZACTAM IN PLASTIC CONTAINER | 20MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050632-003 | AZACTAM IN PLASTIC CONTAINER | 10MG/ML | INJECTABLE / INJECTION | 1989-05-24 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N050632-001 | AZACTAM IN PLASTIC CONTAINER | 40MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 8072bd15b7f6… |
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 |
|---|---|---|---|---|---|---|
| AZACTAM | AZTREONAM | E.R. Squibb & Sons, L.L.C. | 9a105eaf-ee77-4016-beeb-d425a5565db2 | 2025-12-15 | Warnings, Adverse reactions | AZTREONAM |
| Cayston | AZTREONAM | Gilead Sciences, Inc. | 67300ca3-8c53-4ce4-8e86-2c03be1f9b8a | 2025-12-01 | Warnings, Adverse reactions | AZTREONAM |
| AZACTAM | AZTREONAM | A-S Medication Solutions | f9d5515e-54bc-4efc-9f49-8ee3e88c3e01 | 2025-01-09 | Warnings, Adverse reactions | AZTREONAM |
| Aztreonam | AZTREONAM | Hospira, Inc. | d4500795-3b07-4a7d-b432-73cafbb3dbc6 | 2024-06-03 | Warnings, Adverse reactions | AZTREONAM |
| Aztreonam | AZTREONAM | Fresenius Kabi USA, LLC | 5f5ebb63-6ac5-4fb4-bcc1-d069c123eb18 | 2022-05-06 | Warnings, Adverse reactions | AZTREONAM |
| Aztreonam | AZTREONAM | Fresenius Kabi USA, LLC | 302fd27d-0a22-44ea-91fb-1b1ffcf17a1f | 2022-04-30 | Warnings, Adverse reactions | AZTREONAM |
| Aztreonam | AZTREONAM | Fresenius Kabi USA, LLC | c6cf7e13-a04e-47e2-9cec-44a278ee6bec | 2022-03-29 | Warnings, Adverse reactions | AZTREONAM |