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
BLEOMYCIN SULFATE از شرکت MEITHEAL
Abbreviated New Drug Application (ANDA): 205030
Company: MEITHEAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BLEOMYCIN SULFATE | BLEOMYCIN SULFATE | EQ 15 UNITS BASE/VIAL | INJECTABLE;INJECTION | Prescription |
AP |
No | No |
| BLEOMYCIN SULFATE | BLEOMYCIN SULFATE | EQ 30 UNITS BASE/VIAL | 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 |
|---|---|---|---|---|---|---|---|
| 04/20/2018 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
BLEOMYCIN SULFATE
INJECTABLE;INJECTION; EQ 15 UNITS BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BLEOMYCIN SULFATE | BLEOMYCIN SULFATE | EQ 15 UNITS BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065185 | FRESENIUS KABI USA |
| BLEOMYCIN SULFATE | BLEOMYCIN SULFATE | EQ 15 UNITS BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065031 | HOSPIRA |
| BLEOMYCIN SULFATE | BLEOMYCIN SULFATE | EQ 15 UNITS BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 205030 | MEITHEAL |
| BLEOMYCIN SULFATE | BLEOMYCIN SULFATE | EQ 15 UNITS BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065033 | TEVA PHARMS USA |
| BLEOMYCIN SULFATE | BLEOMYCIN SULFATE | EQ 15 UNITS BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065042 | WEST-WARD PHARMS INT |
INJECTABLE;INJECTION; EQ 30 UNITS BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BLEOMYCIN SULFATE | BLEOMYCIN SULFATE | EQ 30 UNITS BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065185 | FRESENIUS KABI USA |
| BLEOMYCIN SULFATE | BLEOMYCIN SULFATE | EQ 30 UNITS BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065031 | HOSPIRA |
| BLEOMYCIN SULFATE | BLEOMYCIN SULFATE | EQ 30 UNITS BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 205030 | MEITHEAL |
| BLEOMYCIN SULFATE | BLEOMYCIN SULFATE | EQ 30 UNITS BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065033 | TEVA PHARMS USA |
| BLEOMYCIN SULFATE | BLEOMYCIN SULFATE | EQ 30 UNITS BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065042 | WEST-WARD PHARMS INT |
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