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
CEFEPIME HYDROCHLORIDE از شرکت ACS DOBFAR
Abbreviated New Drug Application (ANDA): 065441
Company: ACS DOBFAR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFEPIME HYDROCHLORIDE | CEFEPIME HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription |
AP |
No | No |
| CEFEPIME HYDROCHLORIDE | CEFEPIME HYDROCHLORIDE | EQ 2GM 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 |
|---|---|---|---|---|---|---|---|
| 03/20/2008 | ORIG-1 | Approval |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/25/2020 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/25/2020 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/25/2020 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/25/2020 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/25/2020 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/26/2013 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/29/2011 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
CEFEPIME HYDROCHLORIDE
INJECTABLE;INJECTION; EQ 1GM BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEFEPIME HYDROCHLORIDE | CEFEPIME HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065441 | ACS DOBFAR |
| CEFEPIME HYDROCHLORIDE | CEFEPIME HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 203704 | QILU |
| CEFEPIME HYDROCHLORIDE | CEFEPIME HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 091048 | SAGENT PHARMS INC |
| MAXIPIME | CEFEPIME HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050679 | HOSPIRA INC |
INJECTABLE;INJECTION; EQ 2GM BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEFEPIME HYDROCHLORIDE | CEFEPIME HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065441 | ACS DOBFAR |
| CEFEPIME HYDROCHLORIDE | CEFEPIME HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 203704 | QILU |
| CEFEPIME HYDROCHLORIDE | CEFEPIME HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 091048 | SAGENT PHARMS INC |
| MAXIPIME | CEFEPIME HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050679 | HOSPIRA INC |
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