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
BUSPIRONE HYDROCHLORIDE از شرکت IMPAX LABS INC
Abbreviated New Drug Application (ANDA): 074253
Company: IMPAX LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription |
AB |
No | No |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription |
AB |
No | No |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/28/2001 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75253ltr&TA.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/29/2020 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/31/2012 | SUPPL-5 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 06/03/2008 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 03/13/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74253S1&2ltr.pdf |
|
| 03/13/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74253S1&2ltr.pdf |
BUSPIRONE HYDROCHLORIDE
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 202557 | ACCORD HLTHCARE |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 208829 | AMNEAL PHARMS CO |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 078246 | AUROBINDO PHARMA LTD |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 208972 | EPIC PHARMA LLC |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 204582 | HERITAGE PHARMA |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 074253 | IMPAX LABS INC |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 209696 | INVENTIA HLTHCARE |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 076008 | MYLAN |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 075388 | OXFORD PHARMS |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 075521 | RUBICON |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 202330 | STRIDES PHARMA |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 075022 | TEVA |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 210907 | UNICHEM |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 202087 | YILING |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 078888 | ZYDUS PHARMS |
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 202557 | ACCORD HLTHCARE |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 208829 | AMNEAL PHARMS CO |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 078246 | AUROBINDO PHARMA LTD |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 208972 | EPIC PHARMA LLC |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 204582 | HERITAGE PHARMA |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 074253 | IMPAX LABS INC |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 209696 | INVENTIA HLTHCARE |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 076008 | MYLAN |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 075388 | OXFORD PHARMS |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 075521 | RUBICON |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 202330 | STRIDES PHARMA |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 075022 | TEVA |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 210907 | UNICHEM |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 202087 | YILING |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 078888 | ZYDUS PHARMS |
TABLET;ORAL; 15MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET;ORAL | Prescription | No | AB | 202557 | ACCORD HLTHCARE |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET;ORAL | Prescription | No | AB | 208829 | AMNEAL PHARMS CO |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET;ORAL | Prescription | No | AB | 078246 | AUROBINDO PHARMA LTD |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET;ORAL | Prescription | No | AB | 208972 | EPIC PHARMA LLC |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET;ORAL | Prescription | No | AB | 204582 | HERITAGE PHARMA |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET;ORAL | Prescription | No | AB | 074253 | IMPAX LABS INC |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET;ORAL | Prescription | No | AB | 209696 | INVENTIA HLTHCARE |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET;ORAL | Prescription | No | AB | 076008 | MYLAN |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET;ORAL | Prescription | No | AB | 075388 | OXFORD PHARMS |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET;ORAL | Prescription | No | AB | 075521 | RUBICON |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET;ORAL | Prescription | No | AB | 202330 | STRIDES PHARMA |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET;ORAL | Prescription | No | AB | 075022 | TEVA |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET;ORAL | Prescription | No | AB | 210907 | UNICHEM |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET;ORAL | Prescription | No | AB | 202087 | YILING |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET;ORAL | Prescription | No | AB | 078888 | ZYDUS PHARMS |
حتما بخوانید : ALA-CORT از شرکت CROWN LABS
منبع : www.accessdata.fda.gov
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