FDA — authorised 6 September 1995
- Application: NDA020482
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: PRECOSE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Precose in United States
FDA authorised Precose on 6 September 1995
Marketing authorisations
FDA — authorised 24 November 2008
- Application: ANDA078470
- Marketing authorisation holder: HIKMA
- Indication: Labeling
- Status: approved
FDA — authorised 27 July 2011
- Application: ANDA090912
- Marketing authorisation holder: STRIDES PHARMA
- Indication: Not Applicable
- Status: approved
FDA — authorised 13 May 2013
- Application: ANDA202271
- Marketing authorisation holder: AVET LIFESCIENCES
- Indication: Labeling
- Status: approved
Precose 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 Precose approved in United States?
Yes. FDA authorised it on 6 September 1995; FDA authorised it on 24 November 2008; FDA authorised it on 27 July 2011.
Who is the marketing authorisation holder for Precose in United States?
BAYER HLTHCARE holds the US marketing authorisation.