Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214277
Company: NOVITIUM PHARMA
Company: NOVITIUM PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CARBAMAZEPINE | CARBAMAZEPINE | 100MG/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 |
---|---|---|---|---|---|---|---|
10/06/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/09/2024 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
CARBAMAZEPINE
SUSPENSION;ORAL; 100MG/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CARBAMAZEPINE | CARBAMAZEPINE | 100MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 075714 | CHARTWELL RX |
CARBAMAZEPINE | CARBAMAZEPINE | 100MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 214277 | NOVITIUM PHARMA |
TEGRETOL | CARBAMAZEPINE | 100MG/5ML | SUSPENSION;ORAL | Prescription | Yes | AB | 018927 | NOVARTIS |
TERIL | CARBAMAZEPINE | 100MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 076729 | TARO |