Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202961
Company: AMNEAL PHARMS
Company: AMNEAL PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXCARBAZEPINE | OXCARBAZEPINE | 300MG/5ML | SUSPENSION;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 |
---|---|---|---|---|---|---|---|
09/17/2012 | 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 |
---|---|---|---|---|---|
03/01/2023 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
11/01/2022 | SUPPL-6 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
11/01/2022 | SUPPL-5 | Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
||
11/01/2022 | SUPPL-4 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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02/04/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
02/04/2015 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
OXCARBAZEPINE
SUSPENSION;ORAL; 300MG/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OXCARBAZEPINE | OXCARBAZEPINE | 300MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 213183 | ALKEM LABS LTD |
OXCARBAZEPINE | OXCARBAZEPINE | 300MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 202961 | AMNEAL PHARMS |
OXCARBAZEPINE | OXCARBAZEPINE | 300MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 215332 | AUCTA |
OXCARBAZEPINE | OXCARBAZEPINE | 300MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 218278 | BIOCON PHARMA |
OXCARBAZEPINE | OXCARBAZEPINE | 300MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 209652 | BIONPHARMA |
OXCARBAZEPINE | OXCARBAZEPINE | 300MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 212428 | CHARTWELL RX |
OXCARBAZEPINE | OXCARBAZEPINE | 300MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 216749 | HETERO LABS LTD III |
OXCARBAZEPINE | OXCARBAZEPINE | 300MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 217782 | MEDLEY PHARMS |
OXCARBAZEPINE | OXCARBAZEPINE | 300MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 215726 | RUBICON |
OXCARBAZEPINE | OXCARBAZEPINE | 300MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 078734 | SUN PHARM INDS LTD |
TRILEPTAL | OXCARBAZEPINE | 300MG/5ML | SUSPENSION;ORAL | Prescription | Yes | AB | 021285 | NOVARTIS |