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 WEST-WARD PHARMS INT
Abbreviated New Drug Application (ANDA): 065042
Company: WEST-WARD PHARMS INT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BLEOMYCIN SULFATE | BLEOMYCIN SULFATE | EQ 30 UNITS BASE/VIAL | INJECTABLE;INJECTION | Prescription |
AP |
No | No |
| BLEOMYCIN SULFATE | BLEOMYCIN SULFATE | EQ 15 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 |
|---|---|---|---|---|---|---|---|
| 10/17/2001 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/65042ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/30/2011 | SUPPL-6 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/25/2011 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/05/2007 | SUPPL-4 | Labeling |
Label is not available on this site. |
BLEOMYCIN SULFATE
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 |
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 |
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