🇺🇸 Oral contraceptive in United States

Oral contraceptive (Oral contraceptive) regulatory status in United States.

Marketing authorisations

FDA

  • Status: approved

FDA

  • Application: ANDA091690
  • Marketing authorisation holder: NOVAST LABS
  • Local brand name: ETHINYL ESTRADIOL AND LEVONORGESTREL
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

Oral contraceptive in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Oral contraceptive approved in United States?

Yes. FDA has authorised it; FDA has authorised it.

Who is the marketing authorisation holder for Oral contraceptive in United States?

Peking Union Medical College Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.