Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075022
Company: TEVA
Company: TEVA
| 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 |
| 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 |
|---|---|---|---|---|---|---|---|
| 02/28/2002 | 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 |
|---|---|---|---|---|---|
| 05/29/2020 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/27/2012 | SUPPL-16 | Labeling-Container/Carton Labels, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 08/26/2011 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/29/2015 | SUPPL-13 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/18/2008 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 03/16/2007 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 02/26/2003 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 03/26/2004 | SUPPL-1 |
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 | 202087 | AIPING PHARM INC |
| 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 | 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 | 202087 | AIPING PHARM INC |
| 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 | 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 | 202087 | AIPING PHARM INC |
| 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 | 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 | 202087 | AIPING PHARM INC |
| 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 | 078888 | ZYDUS PHARMS |