Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208972
Company: EPIC PHARMA LLC
Company: EPIC PHARMA LLC
| 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 |
|---|---|---|---|---|---|---|---|
| 04/16/2019 | 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 | 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; 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 | 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 | 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 |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 7.5MG | 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 |