Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077801
Company: TARO
Company: TARO
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 |
---|---|---|---|---|---|---|---|
11/15/2007 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/077801_bioeq_rev.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/15/2015 | SUPPL-5 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
01/15/2015 | SUPPL-4 | Labeling-Medication Guide, REMS-Proposal |
Label is not available on this site. |
||
06/29/2010 | SUPPL-1 | Labeling-Package Insert |
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 | 078005 | ANI PHARMS |
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 | 078005 | ANI PHARMS |
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 | 078005 | ANI PHARMS |
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 |