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 |
|---|---|---|---|---|---|---|---|---|---|
| 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… | |
| 2024-05-31 18:47 UTC | 2024-05 | N050632-002 | AZACTAM IN PLASTIC CONTAINER | 20MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N050632-003 | AZACTAM IN PLASTIC CONTAINER | 10MG/ML | INJECTABLE / INJECTION | 1989-05-24 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050632-001 | AZACTAM IN PLASTIC CONTAINER | 40MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050632-002 | AZACTAM IN PLASTIC CONTAINER | 20MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050632-003 | AZACTAM IN PLASTIC CONTAINER | 10MG/ML | INJECTABLE / INJECTION | 1989-05-24 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N050632-001 | AZACTAM IN PLASTIC CONTAINER | 40MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N050632-002 | AZACTAM IN PLASTIC CONTAINER | 20MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N050632-003 | AZACTAM IN PLASTIC CONTAINER | 10MG/ML | INJECTABLE / INJECTION | 1989-05-24 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N050632-001 | AZACTAM IN PLASTIC CONTAINER | 40MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N050632-002 | AZACTAM IN PLASTIC CONTAINER | 20MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N050632-003 | AZACTAM IN PLASTIC CONTAINER | 10MG/ML | INJECTABLE / INJECTION | 1989-05-24 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N050632-001 | AZACTAM IN PLASTIC CONTAINER | 40MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N050632-002 | AZACTAM IN PLASTIC CONTAINER | 20MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N050632-003 | AZACTAM IN PLASTIC CONTAINER | 10MG/ML | INJECTABLE / INJECTION | 1989-05-24 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N050632-001 | AZACTAM IN PLASTIC CONTAINER | 40MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N050632-002 | AZACTAM IN PLASTIC CONTAINER | 20MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N050632-003 | AZACTAM IN PLASTIC CONTAINER | 10MG/ML | INJECTABLE / INJECTION | 1989-05-24 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N050632-001 | AZACTAM IN PLASTIC CONTAINER | 40MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N050632-002 | AZACTAM IN PLASTIC CONTAINER | 20MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N050632-003 | AZACTAM IN PLASTIC CONTAINER | 10MG/ML | INJECTABLE / INJECTION | 1989-05-24 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N050632-001 | AZACTAM IN PLASTIC CONTAINER | 40MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N050632-002 | AZACTAM IN PLASTIC CONTAINER | 20MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N050632-003 | AZACTAM IN PLASTIC CONTAINER | 10MG/ML | INJECTABLE / INJECTION | 1989-05-24 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N050632-001 | AZACTAM IN PLASTIC CONTAINER | 40MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | N050632-002 | AZACTAM IN PLASTIC CONTAINER | 20MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | N050632-003 | AZACTAM IN PLASTIC CONTAINER | 10MG/ML | INJECTABLE / INJECTION | 1989-05-24 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N050632-001 | AZACTAM IN PLASTIC CONTAINER | 40MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N050632-002 | AZACTAM IN PLASTIC CONTAINER | 20MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N050632-003 | AZACTAM IN PLASTIC CONTAINER | 10MG/ML | INJECTABLE / INJECTION | 1989-05-24 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N050632-001 | AZACTAM IN PLASTIC CONTAINER | 40MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N050632-002 | AZACTAM IN PLASTIC CONTAINER | 20MG/ML | INJECTABLE / INJECTION | RLD | 1989-05-24 | c0c555d07b60… |
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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.