Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208819
Company: BIONPHARMA
Company: BIONPHARMA
| 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 |
|---|---|---|---|---|---|---|---|
| 10/22/2018 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208819Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/24/2024 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/01/2023 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/12/2021 | SUPPL-5 | Labeling-Medication Guide, Labeling-Package Insert |
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 |