Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 203993
Company: LUNDBECK PHARMS LLC
Company: LUNDBECK PHARMS LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ONFI | CLOBAZAM | 2.5MG/ML | SUSPENSION;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/14/2012 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203993s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203993Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203993_onfi_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203993Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/12/2024 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202067s008,203993s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/202067Orig1s008, 203993Orig1s010ltr.pdf | |
01/13/2023 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202067s007,203993s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/202067Orig1s007;203993Orig1s009ltr.pdf | |
02/05/2021 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202067s006,203993s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202067Orig1s006; 203993Orig1s008ltr.pdf | |
06/15/2018 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202067s005,203993s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202067Orig1s005,203993Orig1s007ltr.pdf | |
12/16/2016 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203993s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202067Orig1s004,203993Orig1s005ltr.pdf | |
06/16/2016 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/09/2014 | SUPPL-3 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202067s003,203993s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202067Orig1s003,203993Orig1s003ltr.pdf | |
11/21/2013 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202067s002,203993s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202067Orig1s002,203993Orig1s002ltr.pdf | |
01/16/2014 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/12/2024 | SUPPL-10 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202067s008,203993s010lbl.pdf | |
03/12/2024 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202067s008,203993s010lbl.pdf | |
01/13/2023 | SUPPL-9 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202067s007,203993s009lbl.pdf | |
01/13/2023 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202067s007,203993s009lbl.pdf | |
02/05/2021 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202067s006,203993s008lbl.pdf | |
06/15/2018 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202067s005,203993s007lbl.pdf | |
12/16/2016 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203993s005lbl.pdf | |
12/09/2014 | SUPPL-3 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202067s003,203993s003lbl.pdf | |
11/21/2013 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202067s002,203993s002lbl.pdf | |
12/14/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203993s000lbl.pdf |
ONFI
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 |