Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071756
Company: EPIC PHARMA LLC
Company: EPIC PHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OXAZEPAM | OXAZEPAM | 15MG | CAPSULE;ORAL | Prescription | AB | No | No |
| OXAZEPAM | OXAZEPAM | 10MG | CAPSULE;ORAL | Prescription | AB | No | No |
| OXAZEPAM | OXAZEPAM | 30MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 04/19/1988 | 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 |
|---|---|---|---|---|---|
| 01/17/2023 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/05/2021 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/20/2015 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 11/01/2002 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 11/06/2001 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/08/2001 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/11/2001 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/09/1998 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 03/28/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/14/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/14/1993 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 12/12/1989 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/1989 | SUPPL-1 | Labeling |
Label is not available on this site. |
OXAZEPAM
CAPSULE;ORAL; 15MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OXAZEPAM | OXAZEPAM | 15MG | CAPSULE;ORAL | Prescription | No | AB | 072253 | ACTAVIS ELIZABETH |
| OXAZEPAM | OXAZEPAM | 15MG | CAPSULE;ORAL | Prescription | No | AB | 071756 | EPIC PHARMA LLC |
| OXAZEPAM | OXAZEPAM | 15MG | CAPSULE;ORAL | Prescription | No | AB | 218261 | LEADING |
| OXAZEPAM | OXAZEPAM | 15MG | CAPSULE;ORAL | Prescription | No | AB | 071026 | TP ANDA HOLDINGS |
CAPSULE;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OXAZEPAM | OXAZEPAM | 10MG | CAPSULE;ORAL | Prescription | No | AB | 072253 | ACTAVIS ELIZABETH |
| OXAZEPAM | OXAZEPAM | 10MG | CAPSULE;ORAL | Prescription | No | AB | 071756 | EPIC PHARMA LLC |
| OXAZEPAM | OXAZEPAM | 10MG | CAPSULE;ORAL | Prescription | No | AB | 218261 | LEADING |
| OXAZEPAM | OXAZEPAM | 10MG | CAPSULE;ORAL | Prescription | No | AB | 071026 | TP ANDA HOLDINGS |
CAPSULE;ORAL; 30MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OXAZEPAM | OXAZEPAM | 30MG | CAPSULE;ORAL | Prescription | No | AB | 072253 | ACTAVIS ELIZABETH |
| OXAZEPAM | OXAZEPAM | 30MG | CAPSULE;ORAL | Prescription | No | AB | 071756 | EPIC PHARMA LLC |
| OXAZEPAM | OXAZEPAM | 30MG | CAPSULE;ORAL | Prescription | No | AB | 218261 | LEADING |
| OXAZEPAM | OXAZEPAM | 30MG | CAPSULE;ORAL | Prescription | No | AB | 071026 | TP ANDA HOLDINGS |