Application 208564
- Type
- NDA
- Sponsor
- THERAPEUTICSMD INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | IMVEXXY | ESTRADIOL | INSERT;VAGINAL | 0.004MG | Yes | No |
| 002 | IMVEXXY | ESTRADIOL | INSERT;VAGINAL | 0.01MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50261-104 | IMVEXXY | estradiol | TherapeuticsMD, Inc. | NDA | Current |
| 50261-104 | IMVEXXY | estradiol | TherapeuticsMD, Inc. | NDA | Current |
| 50261-104 | IMVEXXY | estradiol | TherapeuticsMD, Inc. | NDA | Current |
| 50261-104 | IMVEXXY | estradiol | TherapeuticsMD, Inc. | NDA | Current |
| 50261-104 | IMVEXXY | estradiol | TherapeuticsMD, Inc. | NDA | Current |
| 50261-104 | IMVEXXY | estradiol | TherapeuticsMD, Inc. | NDA | Current |
| 50261-104 | IMVEXXY | estradiol | TherapeuticsMD, Inc. | NDA | Current |
| 50261-110 | IMVEXXY | estradiol | TherapeuticsMD, Inc. | NDA | Current |
| 50261-110 | IMVEXXY | estradiol | TherapeuticsMD, Inc. | NDA | Current |
| 50261-110 | IMVEXXY | estradiol | TherapeuticsMD, Inc. | NDA | Current |
| 50261-110 | IMVEXXY | estradiol | TherapeuticsMD, Inc. | NDA | Current |
| 50261-110 | IMVEXXY | estradiol | TherapeuticsMD, Inc. | NDA | Current |
| 50261-110 | IMVEXXY | estradiol | TherapeuticsMD, Inc. | NDA | Current |
| 50261-110 | IMVEXXY | estradiol | TherapeuticsMD, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 77575 | SUPPL | 2024-02-20 |
| 77554 | SUPPL | 2024-02-16 |
| 69340 | SUPPL | 2021-11-17 |
| 69335 | SUPPL | 2021-11-17 |
| 61033 | SUPPL | 2019-11-22 |
| 61021 | SUPPL | 2019-11-22 |
| 57394 | ORIG | 2019-02-01 |
| 54411 | ORIG | 2018-06-01 |
| 54392 | ORIG | 2018-05-31 |