Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 201699
Company: CUBIST PHARMS LLC
Company: CUBIST PHARMS LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DIFICID | FIDAXOMICIN | 200MG | TABLET;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 |
---|---|---|---|---|---|---|---|
05/27/2011 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201699s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201699s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201699Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201699Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/28/2020 | SUPPL-13 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201699s013,213138s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/201699Orig1s013,213138Orig1s001ltr.pdf | |
01/24/2020 | SUPPL-12 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201699s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/201699Orig1s012ltr.pdf | |
04/05/2019 | SUPPL-11 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201699s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201699Orig1s011ltr.pdf | |
03/15/2019 | SUPPL-10 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201699s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201699Orig1s010ltr.pdf | |
02/24/2015 | SUPPL-9 | Efficacy-Pediatric |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201699Orig1s009ltr.pdf |
11/18/2013 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/06/2013 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/21/2013 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/04/2013 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201699s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201699Orig1s004ltr_corrected.pdf |
12/19/2012 | SUPPL-3 | 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 |
---|---|---|---|---|---|
05/28/2020 | SUPPL-13 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201699s013,213138s001lbl.pdf | |
05/28/2020 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201699s013,213138s001lbl.pdf | |
01/24/2020 | SUPPL-12 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201699s012lbl.pdf | |
04/05/2019 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201699s011lbl.pdf | |
04/05/2019 | SUPPL-11 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201699s011lbl.pdf | |
03/15/2019 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201699s010lbl.pdf | |
03/15/2019 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201699s010lbl.pdf | |
04/04/2013 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201699s004lbl.pdf |
05/27/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201699s000lbl.pdf |
DIFICID
TABLET;ORAL; 200MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DIFICID | FIDAXOMICIN | 200MG | TABLET;ORAL | Prescription | Yes | AB | 201699 | CUBIST PHARMS LLC |