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 INVENTIA HLTHCARE
Abbreviated New Drug Application (ANDA): 209696
Company: INVENTIA HLTHCARE
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 | 7.5MG | 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 |
BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | 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 |
---|---|---|---|---|---|---|---|
05/03/2018 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
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; 7.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 202557 | ACCORD HLTHCARE |
BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 208829 | AMNEAL PHARMS CO |
BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 078246 | AUROBINDO PHARMA LTD |
BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 208972 | EPIC PHARMA LLC |
BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 209696 | INVENTIA HLTHCARE |
BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 075467 | MYLAN |
BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 076008 | MYLAN |
BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 075521 | RUBICON |
BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 202330 | STRIDES PHARMA |
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 |
TABLET;ORAL; 30MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | No | AB | 202557 | ACCORD HLTHCARE |
BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | No | AB | 208829 | AMNEAL PHARMS CO |
BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | No | AB | 078246 | AUROBINDO PHARMA LTD |
BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | No | AB | 208972 | EPIC PHARMA LLC |
BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | No | AB | 204582 | HERITAGE PHARMA |
BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | No | AB | 209696 | INVENTIA HLTHCARE |
BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | No | AB | 076008 | MYLAN |
BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | No | AB | 078302 | OXFORD PHARMS |
BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | No | AB | 075521 | RUBICON |
BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | No | AB | 202330 | STRIDES PHARMA |
BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | No | AB | 075022 | TEVA |
BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | No | AB | 210907 | UNICHEM |
BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | No | AB | 202087 | YILING |
BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | No | AB | 078888 | ZYDUS PHARMS |
حتما بخوانید : ALBENDAZOLE از شرکت STRIDES PHARMA
منبع : www.accessdata.fda.gov
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