Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214404
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLOBAZAM | CLOBAZAM | 2.5MG/ML | 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 |
---|---|---|---|---|---|---|---|
03/24/2022 | 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 |
---|---|---|---|---|---|
05/15/2024 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
04/26/2023 | SUPPL-1 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
CLOBAZAM
SUSPENSION;ORAL; 2.5MG/ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLOBAZAM | CLOBAZAM | 2.5MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 213039 | ALKEM LABS LTD |
CLOBAZAM | CLOBAZAM | 2.5MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 210039 | AMNEAL |
CLOBAZAM | CLOBAZAM | 2.5MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 214404 | AUROBINDO PHARMA LTD |
CLOBAZAM | CLOBAZAM | 2.5MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 208819 | BIONPHARMA |
CLOBAZAM | CLOBAZAM | 2.5MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 213110 | CHARTWELL MOLECULAR |
CLOBAZAM | CLOBAZAM | 2.5MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 209796 | HETERO LABS LTD III |
CLOBAZAM | CLOBAZAM | 2.5MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 210546 | LUPIN LTD |
CLOBAZAM | CLOBAZAM | 2.5MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 210978 | TARO |
ONFI | CLOBAZAM | 2.5MG/ML | SUSPENSION;ORAL | Prescription | Yes | AB | 203993 | LUNDBECK PHARMS LLC |