FDA — authorised 16 April 1968
- Marketing authorisation holder: WYETH PHARMS
- Status: approved
🇺🇸 Jadelle in United States
FDA authorised Jadelle on 16 April 1968
Marketing authorisations
FDA — authorised 10 December 1990
- Application: NDA020088
- Marketing authorisation holder: WYETH PHARMS INC
- Local brand name: NORPLANT SYSTEM IN PLASTIC CONTAINER
- Indication: IMPLANT — IMPLANTATION
- Status: approved
FDA — authorised 15 August 1996
- Application: NDA020627
- Marketing authorisation holder: WYETH PHARMS INC
- Local brand name: LEVONORGESTREL
- Indication: IMPLANT — IMPLANTATION
- Status: approved
FDA — authorised 22 June 2005
- Application: NDA021258
- Marketing authorisation holder: BAYER HLTHCARE
- Indication: Labeling
- Status: approved
FDA — authorised 24 June 2009
- Application: ANDA078666
- Marketing authorisation holder: WATSON LABS
- Local brand name: LEVONORGESTREL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 August 2009
- Application: ANDA078665
- Marketing authorisation holder: FDN CONSUMER
- Local brand name: LEVONORGESTREL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 July 2012
- Application: ANDA200670
- Marketing authorisation holder: FDN CONSUMER
- Local brand name: LEVONORGESTREL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 January 2013
- Application: NDA203159
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: SKYLA
- Indication: SYSTEM — INTRAUTERINE
- Status: approved
FDA — authorised 11 September 2014
- Application: ANDA202635
- Marketing authorisation holder: SUN PHARM
- Local brand name: OPCICON ONE-STEP
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 June 2015
- Application: ANDA202246
- Marketing authorisation holder: ALVOGEN
- Local brand name: LEVONORGESTREL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 December 2015
- Application: ANDA206867
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: ATHENTIA NEXT
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 March 2016
- Application: ANDA207976
- Marketing authorisation holder: NOVAST LABS
- Local brand name: HER STYLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 March 2016
- Application: ANDA207044
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: LEVONORGESTREL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 July 2018
- Application: ANDA204044
- Marketing authorisation holder: LABORATOIRE HRA
- Local brand name: LEVONORGESTREL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 January 2021
- Application: ANDA206866
- Marketing authorisation holder: AUROBINDO PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 28 February 2025
- Application: ANDA206053
- Marketing authorisation holder: XIROMED
- Indication: Labeling
- Status: approved
The FDA approved Jadelle, a contraceptive implant, for marketing in the United States. The approval was granted to XIROMED on February 28, 2025, through a standard expedited pathway. Jadelle is indicated for use in women of reproductive age for the prevention of pregnancy.
Jadelle in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Bone approved in United States
Frequently asked questions
Is Jadelle approved in United States?
Yes. FDA authorised it on 16 April 1968; FDA authorised it on 10 December 1990; FDA authorised it on 15 August 1996.
Who is the marketing authorisation holder for Jadelle in United States?
WYETH PHARMS holds the US marketing authorisation.