FDA — authorised 9 March 1961
- Application: NDA010976
- Marketing authorisation holder: GD SEARLE LLC
- Local brand name: ENOVID
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Norinyl 1+50 28-Day in United States
FDA authorised Norinyl 1+50 28-Day on 9 March 1961
Marketing authorisations
FDA — authorised 9 March 1961
- Status: approved
FDA — authorised 5 March 1964
- Application: NDA013625
- Marketing authorisation holder: ACTAVIS LABS UT INC
- Local brand name: NORINYL 1+50 21-DAY
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 17 November 1967
- Application: NDA016659
- Marketing authorisation holder: ACTAVIS LABS UT INC
- Local brand name: NORINYL 1+50 28-DAY
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 6 November 1968
- Application: NDA016724
- Marketing authorisation holder: GD SEARLE LLC
- Local brand name: NORINYL 1+80 21-DAY
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 8 November 1968
- Application: NDA016725
- Marketing authorisation holder: GD SEARLE LLC
- Local brand name: NORINYL 1+80 28-DAY
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 12 April 1988
- Application: ANDA071540
- Marketing authorisation holder: HERITAGE PHARMA
- Local brand name: NORETHIN 1/50M-28
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 12 April 1988
- Application: ANDA071539
- Marketing authorisation holder: HERITAGE PHARMA
- Local brand name: NORETHIN 1/50M-21
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 1 July 1988
- Application: ANDA070758
- Marketing authorisation holder: WATSON LABS
- Local brand name: NORETHINDRONE AND MESTRANOL
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 1 July 1988
- Application: ANDA070759
- Marketing authorisation holder: WATSON LABS
- Local brand name: NORETHINDRONE AND MESTRANOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA
- Application: NDA016715
- Marketing authorisation holder: ORTHO MCNEIL PHARM
- Local brand name: ORTHO-NOVUM 1/80 21
- Indication: TABLET — ORAL-21
- Status: approved
Norinyl 1+50 28-Day in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Nephrology approved in United States
Frequently asked questions
Is Norinyl 1+50 28-Day approved in United States?
Yes. FDA authorised it on 9 March 1961; FDA authorised it on 9 March 1961; FDA authorised it on 5 March 1964.
Who is the marketing authorisation holder for Norinyl 1+50 28-Day in United States?
GD SEARLE LLC holds the US marketing authorisation.