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 MYLAN
Abbreviated New Drug Application (ANDA): 075467
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Discontinued |
None |
No | No |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET;ORAL | Prescription |
AB |
No | Yes |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Discontinued |
None |
No | No |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET;ORAL | Discontinued |
None |
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/2001/75467ltr&TA.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/28/2020 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/30/2012 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/13/2008 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 12/23/2002 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/23/2002 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 08/23/2002 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/18/2002 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 02/28/2002 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75467S4ltr.pdf |
|
| 02/28/2002 | SUPPL-4 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75467S4ltr.pdf |
|
| 02/28/2002 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 02/28/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 04/23/2001 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
BUSPIRONE HYDROCHLORIDE
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 |
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