FDA — authorised 27 October 2004
- Application: NDA020958
- Marketing authorisation holder: KENVUE BRANDS
- Indication: Labeling
- Status: approved
🇺🇸 Milk of Magnesia in United States
FDA authorised Milk of Magnesia on 27 October 2004
Marketing authorisations
FDA — authorised 6 February 2008
- Application: ANDA077355
- Marketing authorisation holder: PERRIGO R AND D
- Status: approved
FDA — authorised 4 December 2009
- Application: NDA022456
- Marketing authorisation holder: SANTARUS
- Local brand name: MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE
- Indication: TABLET — ORAL
- Status: approved
Milk of Magnesia in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Milk of Magnesia approved in United States?
Yes. FDA authorised it on 27 October 2004; FDA authorised it on 6 February 2008; FDA authorised it on 4 December 2009.
Who is the marketing authorisation holder for Milk of Magnesia in United States?
KENVUE BRANDS holds the US marketing authorisation.