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
CLONIDINE HYDROCHLORIDE از شرکت HIKMA FARMACEUTICA
Abbreviated New Drug Application (ANDA): 200300
Company: HIKMA FARMACEUTICA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 1MG/10ML (0.1MG/ML) | INJECTABLE;INJECTION | Prescription |
AP |
No | No |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 5MG/10ML (0.5MG/ML) | INJECTABLE;INJECTION | Prescription |
AP |
No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/26/2011 | ORIG-1 | Approval |
Not Applicable |
|
Label is not available on this site. |
CLONIDINE HYDROCHLORIDE
INJECTABLE;INJECTION; 1MG/10ML (0.1MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 1MG/10ML (0.1MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 200673 | FRESENIUS KABI USA |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 1MG/10ML (0.1MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 200300 | HIKMA FARMACEUTICA |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 1MG/10ML (0.1MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 203167 | XGEN PHARMS |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 1MG/10ML (0.1MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 202601 | ZYDUS PHARMS |
| DURACLON | CLONIDINE HYDROCHLORIDE | 1MG/10ML (0.1MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 020615 | MYLAN INSTITUTIONAL |
INJECTABLE;INJECTION; 5MG/10ML (0.5MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 5MG/10ML (0.5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 200673 | FRESENIUS KABI USA |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 5MG/10ML (0.5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 200300 | HIKMA FARMACEUTICA |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 5MG/10ML (0.5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 203167 | XGEN PHARMS |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 5MG/10ML (0.5MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 202601 | ZYDUS PHARMS |
منبع : www.accessdata.fda.gov
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