Application 206333
- Type
- NDA
- Sponsor
- KYTHERA BIOPHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | KYBELLA | DEOXYCHOLIC ACID | SOLUTION;SUBCUTANEOUS | 20MG/2ML (10MG/ML) | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 61168-101 | KYBELLA | Deoxycholic Acid | Kythera Biopharmaceuticals Inc. | NDA | Current |
| 61168-101 | KYBELLA | Deoxycholic Acid | Kythera Biopharmaceuticals Inc. | NDA | Current |
| 61168-101 | KYBELLA | Deoxycholic Acid | Kythera Biopharmaceuticals Inc. | NDA | Current |
| 61168-101 | KYBELLA | Deoxycholic Acid | Kythera Biopharmaceuticals Inc. | NDA | Current |
| 61168-101 | KYBELLA | Deoxycholic Acid | Kythera Biopharmaceuticals Inc. | NDA | Current |
| 61168-101 | KYBELLA | Deoxycholic Acid | Kythera Biopharmaceuticals Inc. | NDA | Current |
| 61168-101 | KYBELLA | Deoxycholic Acid | Kythera Biopharmaceuticals Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 72262 | SUPPL | 2022-10-07 |
| 72257 | SUPPL | 2022-10-06 |
| 63260 | SUPPL | 2020-05-22 |
| 63259 | SUPPL | 2020-05-22 |
| 63206 | SUPPL | 2020-05-21 |
| 63203 | SUPPL | 2020-05-21 |
| 51867 | SUPPL | 2018-01-26 |
| 51087 | SUPPL | 2018-01-18 |
| 43518 | ORIG | 2015-05-28 |
| 24513 | ORIG | 2015-05-28 |
| 40539 | ORIG | 2015-04-29 |
| 32798 | ORIG | 2015-04-29 |