FDA — authorised 2 February 1977
- Application: ANDA085017
- Marketing authorisation holder: KEY PHARMS
- Local brand name: GENAPAX
- Indication: TAMPON — VAGINAL
- Status: approved
FDA authorised Methylrosaniline Chloride on 2 February 1977
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 2 February 1977; FDA has authorised it; FDA has authorised it.
KEY PHARMS holds the US marketing authorisation.