Application 021166
- Type
- NDA
- Sponsor
- ASCEND THERAPS US
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ESTROGEL | ESTRADIOL | GEL;TOPICAL | 0.06% | No | No |
| 002 | ESTROGEL | ESTRADIOL | GEL, METERED;TRANSDERMAL | 0.06% (1.25GM/ACTIVATION) | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 17139-613 | EstroGel | estradiol | ASCEND Therapeutics US, LLC | NDA | Current |
| 17139-617 | EstroGel | estradiol | ASCEND Therapeutics US, LLC | NDA | Current |
| 17139-617 | EstroGel | estradiol | ASCEND Therapeutics US, LLC | NDA | Current |
| 17139-617 | EstroGel | estradiol | ASCEND Therapeutics US, LLC | NDA | Current |
| 17139-617 | EstroGel | estradiol | ASCEND Therapeutics US, LLC | NDA | Current |
| 17139-617 | EstroGel | estradiol | ASCEND Therapeutics US, LLC | NDA | Current |
| 17139-617 | EstroGel | estradiol | ASCEND Therapeutics US, LLC | NDA | Current |
| 17139-617 | EstroGel | estradiol | ASCEND Therapeutics US, LLC | NDA | Current |
Documents
| Document | Title | Submission type | Submission no. | Date | Storage |
|---|---|---|---|---|---|
| 77578 | 0 | SUPPL | 19 | 2024-02-20 | Cached in FDA.report object storage |
| 77555 | 0 | SUPPL | 19 | 2024-02-16 | Cached in FDA.report object storage |
| 74979 | 0 | SUPPL | 18 | 2023-08-03 | Cached in FDA.report object storage |
| 74974 | 0 | SUPPL | 18 | 2023-08-02 | Cached in FDA.report object storage |
| 69464 | 0 | SUPPL | 17 | 2021-12-03 | Cached in FDA.report object storage |
| 69439 | 0 | SUPPL | 17 | 2021-12-01 | Cached in FDA.report object storage |
| 50275 | 0 | SUPPL | 15 | 2017-11-02 | Cached in FDA.report object storage |
| 26956 | 0 | SUPPL | 10 | 2014-03-27 | Cached in FDA.report object storage |
| 14545 | 0 | SUPPL | 10 | 2014-03-27 | Cached in FDA.report object storage |
| 14544 | 0 | SUPPL | 7 | 2008-01-30 | Cached in FDA.report object storage |
| 26955 | 0 | SUPPL | 7 | 2008-01-29 | Cached in FDA.report object storage |
| 4519 | 0 | SUPPL | 5 | 2007-07-30 | Cached in FDA.report object storage |
| 36254 | 0 | SUPPL | 5 | 2007-07-27 | Cached in FDA.report object storage |
| 41999 | 0 | ORIG | 1 | 2005-06-23 | FDA source fallback |
| 26954 | 0 | SUPPL | 1 | 2004-09-15 | FDA source fallback |
| 14543 | 0 | ORIG | 1 | 2004-04-05 | FDA source fallback |
| 4518 | 0 | ORIG | 1 | 2004-03-02 | FDA source fallback |