Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216749
Company: HETERO LABS LTD III
Company: HETERO LABS LTD III
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 |
---|---|---|---|---|---|---|---|
10/20/2023 | ORIG-1 | Approval | STANDARD |
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 |