Application 211328
- Type
- ANDA
- Sponsor
- MAYNE PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HALOETTE | ETHINYL ESTRADIOL; ETONOGESTREL | RING;VAGINAL | 0.015MG/24HR;0.12MG/24HR | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51862-148 | HALOETTE | etonogestrel and ethinyl estradiol | Mayne Pharma Inc. | ANDA | Current |