اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
BUSULFAN از شرکت AMNEAL
Abbreviated New Drug Application (ANDA): 209580
Company: AMNEAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUSULFAN | BUSULFAN | 6MG/ML | INJECTABLE;INJECTION | Prescription |
AP |
No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/18/2017 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/31/2019 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/31/2019 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
BUSULFAN
INJECTABLE;INJECTION; 6MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUSULFAN | BUSULFAN | 6MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210148 | ACCORD HLTHCARE INC |
| BUSULFAN | BUSULFAN | 6MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 202259 | AM REGENT |
| BUSULFAN | BUSULFAN | 6MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209580 | AMNEAL |
| BUSULFAN | BUSULFAN | 6MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210448 | APOTEX |
| BUSULFAN | BUSULFAN | 6MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 205106 | ATHENEX INC |
| BUSULFAN | BUSULFAN | 6MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 205672 | HOSPIRA INC |
| BUSULFAN | BUSULFAN | 6MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212127 | MEITHEAL |
| BUSULFAN | BUSULFAN | 6MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 208536 | MYLAN INSTITUTIONAL |
| BUSULFAN | BUSULFAN | 6MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 207794 | NEXUS PHARMS |
| BUSULFAN | BUSULFAN | 6MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 207050 | PHARMASCIENCE INC |
| BUSULFAN | BUSULFAN | 6MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210931 | SHILPA |
| BUSULFEX | BUSULFAN | 6MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020954 | OTSUKA PHARM |
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