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 MYLAN LABS LTD
Abbreviated New Drug Application (ANDA): 209592
Company: MYLAN LABS LTD
| 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 |
|---|---|---|---|---|---|---|---|
| 03/21/2018 | ORIG-1 | Approval |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209592Orig1s000lbl.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/21/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209592Orig1s000lbl.pdf |
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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