FDA — authorised 2 January 1973
- Application: NDA017060
- Marketing authorisation holder: TEVA BRANDED PHARM
- Local brand name: NOR-QD
- Indication: TABLET — ORAL-28
- Status: approved
🇺🇸 Progestin in United States
FDA authorised Progestin on 2 January 1973
Marketing authorisations
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
- Local brand name: NORETHINDRONE
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 19 January 2012
- Application: ANDA091636
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: ALYACEN 777
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 March 2013
- Application: ANDA091323
- Marketing authorisation holder: LUPIN LTD
- Local brand name: JENCYCLA
- Indication: TABLET — ORAL-28
- 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 13 September 2013
- Application: ANDA202014
- Marketing authorisation holder: NOVAST LABS
- Local brand name: NORETHINDRONE
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 23 September 2016
- Application: ANDA207304
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: INCASSIA
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 13 December 2016
- Application: ANDA206807
- Marketing authorisation holder: NAARI PTE
- Local brand name: NORETHINDRONE
- Indication: TABLET — ORAL-28
- Status: approved
FDA
- Status: approved
FDA
- Application: NDA010895
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: NORLUTIN
- Indication: TABLET — ORAL
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Progestin approved in United States?
Yes. FDA authorised it on 2 January 1973; FDA authorised it on 23 April 2010; FDA authorised it on 22 July 2010.
Who is the marketing authorisation holder for Progestin in United States?
TEVA BRANDED PHARM holds the US marketing authorisation.