Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076729
Company: TARO
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TERIL | 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 |
---|---|---|---|---|---|---|---|
09/20/2004 | 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 |
---|---|---|---|---|---|
02/28/2020 | SUPPL-17 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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11/08/2016 | SUPPL-13 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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11/08/2016 | SUPPL-11 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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06/13/2013 | SUPPL-9 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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01/24/2012 | SUPPL-8 | REMS-Proposal, Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
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01/27/2010 | SUPPL-4 | Labeling |
Label is not available on this site. |
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04/17/2008 | SUPPL-2 | Labeling |
Label is not available on this site. |
TERIL
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 |