NDC 51862-148

HALOETTE

Etonogestrel And Ethinyl Estradiol

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 ID51862-148_e2064cbe-b7be-4e2d-9950-80dbc6a7b84f
NDC51862-148
Product TypeHuman Prescription Drug
Proprietary NameHALOETTE
Generic NameEtonogestrel And Ethinyl Estradiol
Dosage FormInsert, Extended Release
Route of AdministrationVAGINAL
Marketing Start Date2022-12-01
Marketing CategoryANDA /
Application NumberANDA211328
Labeler NameMayne Pharma Inc.
Substance NameETHINYL ESTRADIOL; ETONOGESTREL
Active Ingredient Strength0 mg/d; mg/d
Pharm ClassesEstrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 51862-148-03

3 POUCH in 1 CARTON (51862-148-03) > 21 d in 1 POUCH (51862-148-01)
Marketing Start Date2022-12-01
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "HALOETTE" or generic name "Etonogestrel And Ethinyl Estradiol"

NDCBrand NameGeneric Name
51862-148HALOETTEetonogestrel and ethinyl estradiol
65162-469EluRyngEtonogestrel and Ethinyl Estradiol
0093-7679Etonogestrel and Ethinyl EstradiolEtonogestrel and Ethinyl Estradiol
50090-5959Etonogestrel/Ethinyl Estradioletonogestrel and ethinyl estradiol
66993-605Etonogestrel/Ethinyl Estradioletonogestrel and ethinyl estradiol
0052-0273NuvaRingetonogestrel and ethinyl estradiol
50090-1008NUVARINGetonogestrel and ethinyl estradiol
50090-5611NUVARINGetonogestrel and ethinyl estradiol
76413-131NuvaRingetonogestrel and ethinyl estradiol
78206-146NuvaRingetonogestrel and ethinyl estradiol

Trademark Results [HALOETTE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HALOETTE
HALOETTE
88018774 5675232 Live/Registered
NOVALON, SOCIETE ANONYME
2018-06-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.