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
BACLOFEN از شرکت MAIA PHARMS INC
Abbreviated New Drug Application (ANDA): 210048
Company: MAIA PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BACLOFEN | BACLOFEN | 0.5MG/ML | INJECTABLE;INTRATHECAL | Prescription |
AP |
No | No |
| BACLOFEN | BACLOFEN | 2MG/ML | INJECTABLE;INTRATHECAL | 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 |
|---|---|---|---|---|---|---|---|
| 09/11/2019 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
BACLOFEN
INJECTABLE;INTRATHECAL; 0.5MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BACLOFEN | BACLOFEN | 0.5MG/ML | INJECTABLE;INTRATHECAL | Prescription | No | AP | 091193 | EMERALD INTL LTD |
| BACLOFEN | BACLOFEN | 0.5MG/ML | INJECTABLE;INTRATHECAL | Prescription | No | AP | 210048 | MAIA PHARMS INC |
| BACLOFEN | BACLOFEN | 0.5MG/ML | INJECTABLE;INTRATHECAL | Prescription | No | AP | 209592 | MYLAN LABS LTD |
| GABLOFEN | BACLOFEN | 0.5MG/ML | INJECTABLE;INTRATHECAL | Prescription | Yes | AP | 022462 | PIRAMAL CRITICAL |
| LIORESAL | BACLOFEN | 0.5MG/ML | INJECTABLE;INTRATHECAL | Prescription | Yes | AP | 020075 | SAOL THERAPS RES LTD |
INJECTABLE;INTRATHECAL; 2MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BACLOFEN | BACLOFEN | 2MG/ML | INJECTABLE;INTRATHECAL | Prescription | No | AP | 091193 | EMERALD INTL LTD |
| BACLOFEN | BACLOFEN | 2MG/ML | INJECTABLE;INTRATHECAL | Prescription | No | AP | 210048 | MAIA PHARMS INC |
| BACLOFEN | BACLOFEN | 2MG/ML | INJECTABLE;INTRATHECAL | Prescription | No | AP | 209592 | MYLAN LABS LTD |
| GABLOFEN | BACLOFEN | 2MG/ML | INJECTABLE;INTRATHECAL | Prescription | Yes | AP | 022462 | PIRAMAL CRITICAL |
| LIORESAL | BACLOFEN | 2MG/ML | INJECTABLE;INTRATHECAL | Prescription | Yes | AP | 020075 | SAOL THERAPS RES LTD |
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