Application 210132
- Type
- NDA
- Sponsor
- THERAPEUTICSMD INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BIJUVA | ESTRADIOL; PROGESTERONE | CAPSULE;ORAL | 1MG;100MG | Yes | Yes |
| 002 | BIJUVA | ESTRADIOL; PROGESTERONE | CAPSULE;ORAL | 0.5MG;100MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50261-211 | Bijuva | estradiol and progesterone | TherapeuticsMD, Inc. | NDA | Current |
| 50261-211 | Bijuva | estradiol and progesterone | TherapeuticsMD, Inc. | NDA | Current |
| 50261-211 | Bijuva | estradiol and progesterone | TherapeuticsMD, Inc. | NDA | Current |
| 50261-211 | Bijuva | estradiol and progesterone | TherapeuticsMD, Inc. | NDA | Current |
| 50261-211 | Bijuva | estradiol and progesterone | TherapeuticsMD, Inc. | NDA | Current |
| 50261-211 | Bijuva | estradiol and progesterone | TherapeuticsMD, Inc. | NDA | Current |