Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078069
Company: BRECKENRIDGE PHARM
Company: BRECKENRIDGE PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OXCARBAZEPINE | OXCARBAZEPINE | 150MG | TABLET;ORAL | Prescription | AB | No | No |
| OXCARBAZEPINE | OXCARBAZEPINE | 300MG | TABLET;ORAL | Prescription | AB | No | No |
| OXCARBAZEPINE | OXCARBAZEPINE | 600MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/11/2008 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/078069_bioeq_rev-oxcarbazepine tabs.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/08/2023 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/28/2020 | SUPPL-13 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/28/2020 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/03/2015 | SUPPL-9 | Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/03/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/20/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/20/2015 | SUPPL-4 | Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/29/2011 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
||
| 08/30/2011 | SUPPL-2 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 06/29/2010 | SUPPL-1 | Labeling |
Label is not available on this site. |
OXCARBAZEPINE
TABLET;ORAL; 150MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OXCARBAZEPINE | OXCARBAZEPINE | 150MG | TABLET;ORAL | Prescription | No | AB | 215939 | ANNORA PHARMA |
| OXCARBAZEPINE | OXCARBAZEPINE | 150MG | TABLET;ORAL | Prescription | No | AB | 078069 | BRECKENRIDGE PHARM |
| OXCARBAZEPINE | OXCARBAZEPINE | 150MG | TABLET;ORAL | Prescription | No | AB | 077802 | GLENMARK PHARMS LTD |
| OXCARBAZEPINE | OXCARBAZEPINE | 150MG | TABLET;ORAL | Prescription | No | AB | 077747 | RUBICON |
| OXCARBAZEPINE | OXCARBAZEPINE | 150MG | TABLET;ORAL | Prescription | No | AB | 207717 | RUBICON |
| OXCARBAZEPINE | OXCARBAZEPINE | 150MG | TABLET;ORAL | Prescription | No | AB | 077794 | SUN PHARM INDS |
| OXCARBAZEPINE | OXCARBAZEPINE | 150MG | TABLET;ORAL | Prescription | No | AB | 077801 | TARO |
| TRILEPTAL | OXCARBAZEPINE | 150MG | TABLET;ORAL | Prescription | Yes | AB | 021014 | NOVARTIS |
TABLET;ORAL; 300MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OXCARBAZEPINE | OXCARBAZEPINE | 300MG | TABLET;ORAL | Prescription | No | AB | 215939 | ANNORA PHARMA |
| OXCARBAZEPINE | OXCARBAZEPINE | 300MG | TABLET;ORAL | Prescription | No | AB | 078069 | BRECKENRIDGE PHARM |
| OXCARBAZEPINE | OXCARBAZEPINE | 300MG | TABLET;ORAL | Prescription | No | AB | 077802 | GLENMARK PHARMS LTD |
| OXCARBAZEPINE | OXCARBAZEPINE | 300MG | TABLET;ORAL | Prescription | No | AB | 077747 | RUBICON |
| OXCARBAZEPINE | OXCARBAZEPINE | 300MG | TABLET;ORAL | Prescription | No | AB | 207717 | RUBICON |
| OXCARBAZEPINE | OXCARBAZEPINE | 300MG | TABLET;ORAL | Prescription | No | AB | 077794 | SUN PHARM INDS |
| OXCARBAZEPINE | OXCARBAZEPINE | 300MG | TABLET;ORAL | Prescription | No | AB | 077801 | TARO |
| TRILEPTAL | OXCARBAZEPINE | 300MG | TABLET;ORAL | Prescription | Yes | AB | 021014 | NOVARTIS |
TABLET;ORAL; 600MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OXCARBAZEPINE | OXCARBAZEPINE | 600MG | TABLET;ORAL | Prescription | No | AB | 215939 | ANNORA PHARMA |
| OXCARBAZEPINE | OXCARBAZEPINE | 600MG | TABLET;ORAL | Prescription | No | AB | 078069 | BRECKENRIDGE PHARM |
| OXCARBAZEPINE | OXCARBAZEPINE | 600MG | TABLET;ORAL | Prescription | No | AB | 077802 | GLENMARK PHARMS LTD |
| OXCARBAZEPINE | OXCARBAZEPINE | 600MG | TABLET;ORAL | Prescription | No | AB | 077747 | RUBICON |
| OXCARBAZEPINE | OXCARBAZEPINE | 600MG | TABLET;ORAL | Prescription | No | AB | 207717 | RUBICON |
| OXCARBAZEPINE | OXCARBAZEPINE | 600MG | TABLET;ORAL | Prescription | No | AB | 077794 | SUN PHARM INDS |
| OXCARBAZEPINE | OXCARBAZEPINE | 600MG | TABLET;ORAL | Prescription | No | AB | 077801 | TARO |
| TRILEPTAL | OXCARBAZEPINE | 600MG | TABLET;ORAL | Prescription | Yes | AB | 021014 | NOVARTIS |