HALOETTE is a Vaginal Insert, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Mayne Pharma Inc.. The primary component is Ethinyl Estradiol; Etonogestrel.
| Product ID | 51862-148_e2064cbe-b7be-4e2d-9950-80dbc6a7b84f |
| NDC | 51862-148 |
| Product Type | Human Prescription Drug |
| Proprietary Name | HALOETTE |
| Generic Name | Etonogestrel And Ethinyl Estradiol |
| Dosage Form | Insert, Extended Release |
| Route of Administration | VAGINAL |
| Marketing Start Date | 2022-12-01 |
| Marketing Category | ANDA / |
| Application Number | ANDA211328 |
| Labeler Name | Mayne Pharma Inc. |
| Substance Name | ETHINYL ESTRADIOL; ETONOGESTREL |
| Active Ingredient Strength | 0 mg/d; mg/d |
| Pharm Classes | Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2022-12-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 51862-148 | HALOETTE | etonogestrel and ethinyl estradiol |
| 65162-469 | EluRyng | Etonogestrel and Ethinyl Estradiol |
| 0093-7679 | Etonogestrel and Ethinyl Estradiol | Etonogestrel and Ethinyl Estradiol |
| 50090-5959 | Etonogestrel/Ethinyl Estradiol | etonogestrel and ethinyl estradiol |
| 66993-605 | Etonogestrel/Ethinyl Estradiol | etonogestrel and ethinyl estradiol |
| 0052-0273 | NuvaRing | etonogestrel and ethinyl estradiol |
| 50090-1008 | NUVARING | etonogestrel and ethinyl estradiol |
| 50090-5611 | NUVARING | etonogestrel and ethinyl estradiol |
| 76413-131 | NuvaRing | etonogestrel and ethinyl estradiol |
| 78206-146 | NuvaRing | etonogestrel and ethinyl estradiol |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() HALOETTE 88018774 5675232 Live/Registered |
NOVALON, SOCIETE ANONYME 2018-06-28 |