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 NORTHSTAR HLTHCARE
Abbreviated New Drug Application (ANDA): 078401
Company: NORTHSTAR HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Prescription |
AB |
No | No |
| BACLOFEN | BACLOFEN | 10MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/18/2009 | 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 |
|---|---|---|---|---|---|
| 11/03/2020 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/03/2020 | SUPPL-11 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 04/15/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/15/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/28/2011 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/27/2010 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
BACLOFEN
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 |
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 |
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