Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 206333
Company: KYTHERA BIOPHARMS
Company: KYTHERA BIOPHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
KYBELLA | DEOXYCHOLIC ACID | 20MG/2ML (10MG/ML) | SOLUTION;SUBCUTANEOUS | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
04/29/2015 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206333Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206333Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206333Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206333Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/05/2022 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206333s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206333Orig1s005ltr.pdf | |
05/20/2020 | SUPPL-3 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206333s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206333Orig1s002, s003ltr.pdf | |
05/20/2020 | SUPPL-2 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206333s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206333Orig1s002, s003ltr.pdf | |
01/18/2018 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206333s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206333Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/05/2022 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206333s005lbl.pdf | |
05/20/2020 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206333s002s003lbl.pdf | |
05/20/2020 | SUPPL-3 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206333s002s003lbl.pdf | |
05/20/2020 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206333s002s003lbl.pdf | |
05/20/2020 | SUPPL-2 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206333s002s003lbl.pdf | |
01/18/2018 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206333s001lbl.pdf | |
04/29/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206333Orig1s000lbl.pdf |
KYBELLA
SOLUTION;SUBCUTANEOUS; 20MG/2ML (10MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEOXYCHOLIC ACID | DEOXYCHOLIC ACID | 20MG/2ML (10MG/ML) | SOLUTION;SUBCUTANEOUS | Prescription | No | AP | 212296 | SLAYBACK PHARMA LLC |
KYBELLA | DEOXYCHOLIC ACID | 20MG/2ML (10MG/ML) | SOLUTION;SUBCUTANEOUS | Prescription | Yes | AP | 206333 | KYTHERA BIOPHARMS |