FDA — authorised 2 January 1973
- Application: NDA017060
- Marketing authorisation holder: TEVA BRANDED PHARM
- Local brand name: NOR-QD
- Indication: TABLET — ORAL-28
- Status: approved
🇺🇸 NORETHINDRONE in United States
FDA authorised NORETHINDRONE on 2 January 1973 · 5,074 US adverse-event reports
Marketing authorisations
FDA — authorised 31 May 2006
- Application: ANDA075951
- Marketing authorisation holder: BARR
- Indication: Labeling
- Status: approved
FDA — authorised 23 April 2010
- Application: ANDA090454
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: HEATHER
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 22 July 2010
- Application: ANDA091209
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: NORETHINDRONE
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 19 September 2011
- Application: ANDA091325
- Marketing authorisation holder: LUPIN LTD
- Status: supplemented
FDA — authorised 30 July 2012
- Application: ANDA200275
- Marketing authorisation holder: AMNEAL PHARMS
- Status: approved
FDA — authorised 31 July 2012
- Application: ANDA091634
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Indication: Labeling
- Status: approved
FDA — authorised 12 June 2013
- Application: ANDA200980
- Marketing authorisation holder: XIROMED
- Local brand name: NORETHINDRONE
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 1 August 2013
- Application: ANDA202260
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: NORETHINDRONE
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 13 September 2013
- Application: ANDA200961
- Marketing authorisation holder: NOVAST LABS
- Local brand name: NORETHINDRONE
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 23 April 2014
- Application: ANDA203371
- Marketing authorisation holder: XIROMED
- Status: approved
FDA — authorised 2 April 2015
- Application: ANDA203038
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Status: approved
FDA — authorised 3 June 2016
- Application: ANDA203435
- Marketing authorisation holder: NOVAST LABS
- Status: supplemented
FDA — authorised 13 December 2016
- Application: ANDA206807
- Marketing authorisation holder: NAARI PTE
- Local brand name: NORETHINDRONE
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 5 November 2018
- Application: ANDA206490
- Marketing authorisation holder: INGENUS PHARMS LLC
- Status: approved
FDA — authorised 7 February 2022
- Application: ANDA204847
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Indication: Labeling
- Status: approved
FDA — authorised 29 April 2022
- Application: ANDA206864
- Marketing authorisation holder: NAARI PTE
- Indication: Labeling
- Status: approved
FDA
- Application: NDA010895
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: NORLUTIN
- Indication: TABLET — ORAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 5,074
Most-reported reactions
- Nausea — 708 reports (13.95%)
- Headache — 703 reports (13.85%)
- Fatigue — 582 reports (11.47%)
- Hot Flush — 494 reports (9.74%)
- Drug Ineffective — 478 reports (9.42%)
- Off Label Use — 457 reports (9.01%)
- Pain — 449 reports (8.85%)
- Dizziness — 418 reports (8.24%)
- Abdominal Pain — 404 reports (7.96%)
- Diarrhoea — 381 reports (7.51%)
NORETHINDRONE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is NORETHINDRONE approved in United States?
Yes. FDA authorised it on 2 January 1973; FDA authorised it on 31 May 2006; FDA authorised it on 23 April 2010.
Who is the marketing authorisation holder for NORETHINDRONE in United States?
TEVA BRANDED PHARM holds the US marketing authorisation.