Application 212313
- Type
- ANDA
- Sponsor
- PRASCO LABS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ESTRADIOL | ESTRADIOL | CREAM;VAGINAL | 0.01% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 66993-002 | Estradiol Vaginal Cream | estradiol | Prasco Laboratories | ANDA | Current |