Application 204017
- Type
- NDA
- Sponsor
- AGILE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TWIRLA | ETHINYL ESTRADIOL; LEVONORGESTREL | SYSTEM;TRANSDERMAL | 0.03MG/24HR;0.12MG/24HR | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 71671-100 | Twirla | levonorgestrel/ethinyl estradiol | Agile Therapeutics, Inc. | NDA | Current |
| 71671-100 | Twirla | levonorgestrel/ethinyl estradiol | Agile Therapeutics, Inc. | NDA | Current |
| 71671-100 | Twirla | levonorgestrel/ethinyl estradiol | Agile Therapeutics, Inc. | NDA | Current |