Application 205139
- Type
- ANDA
- Sponsor
- ACTAVIS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUSULFAN | BUSULFAN | INJECTABLE;INJECTION | 6MG/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A205139-001 | BUSULFAN | BUSULFAN | 6MG/ML | INJECTABLE / INJECTION | 2017-12-08 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | A205139-001 | BUSULFAN | 6MG/ML | INJECTABLE / INJECTION | 2017-12-08 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A205139-001 | BUSULFAN | 6MG/ML | INJECTABLE / INJECTION | 2017-12-08 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A205139-001 | BUSULFAN | 6MG/ML | INJECTABLE / INJECTION | 2017-12-08 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A205139-001 | BUSULFAN | 6MG/ML | INJECTABLE / INJECTION | 2017-12-08 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A205139-001 | AP | 1 | 74a2ff9319b5… |
| 2020-11-12 02:37 UTC | 2020-11 | A205139-001 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A205139-001 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A205139-001 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A205139-001 | AP | 1 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| Busulfan | BUSULFAN | Sagent Pharmaceuticals | 086a715e-4958-4bb5-9ebd-86171e6b6203 | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | Busulfan BUSULFAN |
| MYLERAN | BUSULFAN | Waylis Therapeutics LLC | 2da33e5b-dcfb-4cdf-b163-50398e42f41c | 2025-01-08 | Boxed warning, Warnings, Adverse reactions | BUSULFAN |
| Busulfan | BUSULFAN | Eugia US LLC | 06883ac0-4b2a-4f26-89bf-512d37b9ba7f | 2024-06-27 | Boxed warning, Warnings, Adverse reactions | Busulfan BUSULFAN |
| Busulfan | BUSULFAN | Accord Healthcare, Inc | fe0ddd44-ef02-4827-b164-7fcbb45bcc1b | 2024-01-05 | Boxed warning, Warnings, Adverse reactions | Busulfan BUSULFAN |
| Busulfan | BUSULFAN | Pharmascience Inc. | d0fe44f9-7747-4909-b927-3b24aa6e7e09 | 2022-05-18 | Boxed warning, Warnings, Adverse reactions | Busulfan BUSULFAN |
| BUSULFAN | BUSULFAN | Hospira, Inc. | b9c7f0dc-988d-466e-8031-400ec4f60f21 | 2021-08-09 | Boxed warning, Warnings, Adverse reactions | BUSULFAN BUSULFAN |
| Busulfan | BUSULFAN | Meitheal Pharmaceuticals Inc. | dc384f16-4e25-458e-874c-553f81c6d8c9 | 2021-06-14 | Boxed warning, Warnings, Adverse reactions | Busulfan BUSULFAN |
| Busulfan | BUSULFAN | Meitheal Pharmaceuticals Inc. | 6e68ab21-19bd-4b7e-b8d0-bf284d5af183 | 2021-06-14 | Boxed warning, Warnings, Adverse reactions | Busulfan BUSULFAN |
| Busulfan | BUSULFAN | Amneal Pharmaceuticals LLC | ac9448da-37ad-4609-9aef-eedf8be0f69c | 2020-09-23 | Boxed warning, Warnings, Adverse reactions | Busulfan BUSULFAN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.