Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209308
Company: BRECKENRIDGE
Company: BRECKENRIDGE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLOBAZAM | CLOBAZAM | 10MG | TABLET;ORAL | Prescription | AB | No | No |
CLOBAZAM | CLOBAZAM | 20MG | TABLET;ORAL | Discontinued | None | No | No |
CLOBAZAM | CLOBAZAM | 5MG | TABLET;ORAL | Discontinued | None | 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 |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/01/2023 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
09/28/2021 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
CLOBAZAM
TABLET;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLOBAZAM | CLOBAZAM | 10MG | TABLET;ORAL | Prescription | No | AB | 212714 | ALKEM LABS LTD |
CLOBAZAM | CLOBAZAM | 10MG | TABLET;ORAL | Prescription | No | AB | 209718 | AMNEAL PHARMS CO |
CLOBAZAM | CLOBAZAM | 10MG | TABLET;ORAL | Prescription | No | AB | 208825 | BIONPHARMA |
CLOBAZAM | CLOBAZAM | 10MG | TABLET;ORAL | Prescription | No | AB | 209308 | BRECKENRIDGE |
CLOBAZAM | CLOBAZAM | 10MG | TABLET;ORAL | Prescription | No | AB | 209795 | HETERO LABS LTD III |
CLOBAZAM | CLOBAZAM | 10MG | TABLET;ORAL | Prescription | No | AB | 210545 | LUPIN LTD |
CLOBAZAM | CLOBAZAM | 10MG | TABLET;ORAL | Prescription | No | AB | 211711 | MICRO LABS |
CLOBAZAM | CLOBAZAM | 10MG | TABLET;ORAL | Prescription | No | AB | 213404 | MSN |
CLOBAZAM | CLOBAZAM | 10MG | TABLET;ORAL | Prescription | No | AB | 209808 | PIRAMAL HLTHCARE UK |
CLOBAZAM | CLOBAZAM | 10MG | TABLET;ORAL | Prescription | No | AB | 209687 | UPSHER SMITH LABS |
CLOBAZAM | CLOBAZAM | 10MG | TABLET;ORAL | Prescription | No | AB | 211449 | ZYDUS PHARMS |
ONFI | CLOBAZAM | 10MG | TABLET;ORAL | Prescription | Yes | AB | 202067 | LUNDBECK PHARMS LLC |