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 RUBICON
Abbreviated New Drug Application (ANDA): 209102
Company: RUBICON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BACLOFEN | BACLOFEN | 5MG | TABLET;ORAL | Prescription |
AB |
No | No |
| BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription |
AB |
No | No |
| BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 11/28/2017 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209102Orig1s000ltr.pdf |
BACLOFEN
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BACLOFEN | BACLOFEN | 5MG | TABLET;ORAL | Prescription | No | AB | 077971 | IMPAX |
| BACLOFEN | BACLOFEN | 5MG | TABLET;ORAL | Prescription | No | AB | 212378 | INNOGENIX |
| BACLOFEN | BACLOFEN | 5MG | TABLET;ORAL | Prescription | No | AB | 077241 | LANNETT CO INC |
| BACLOFEN | BACLOFEN | 5MG | TABLET;ORAL | Prescription | No | AB | 209102 | RUBICON |
| BACLOFEN | BACLOFEN | 5MG | TABLET;ORAL | Prescription | No | AB | 211659 | ZYDUS |
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 214099 | AUROBINDO PHARMA LTD |
| BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 214114 | BEXIMCO PHARMS USA |
| BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 211555 | EYWA PHARMA |
| BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 077971 | IMPAX |
| BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 212378 | INNOGENIX |
| BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 072234 | IVAX SUB TEVA PHARMS |
| BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 077241 | LANNETT CO INC |
| BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 078401 | NORTHSTAR HLTHCARE |
| BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 078504 | NORTHSTAR HLTHCARE |
| BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 077088 | OXFORD PHARMS |
| BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 209102 | RUBICON |
| BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 212067 | UNICHEM |
| BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 074584 | UPSHER SMITH LABS |
| BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 077068 | VINTAGE PHARMS |
| BACLOFEN | BACLOFEN | 10MG | TABLET;ORAL | Prescription | No | AB | 211659 | ZYDUS |
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 214099 | AUROBINDO PHARMA LTD |
| BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 214114 | BEXIMCO PHARMS USA |
| BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 211555 | EYWA PHARMA |
| BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 077971 | IMPAX |
| BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 212378 | INNOGENIX |
| BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 072235 | IVAX SUB TEVA PHARMS |
| BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 077241 | LANNETT CO INC |
| BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 078401 | NORTHSTAR HLTHCARE |
| BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 077088 | OXFORD PHARMS |
| BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 209102 | RUBICON |
| BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 212067 | UNICHEM |
| BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 074584 | UPSHER SMITH LABS |
| BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 077068 | VINTAGE PHARMS |
| BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription | No | AB | 211659 | ZYDUS |
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