FDA — authorised 26 January 1959
- Application: NDA011721
- Marketing authorisation holder: LEDERLE
- Local brand name: NEPTAZANE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Neptazane in United States
FDA authorised Neptazane on 26 January 1959
Marketing authorisations
FDA — authorised 26 January 1959
- Marketing authorisation holder: LEDERLE
- Status: approved
FDA — authorised 30 June 1993
- Application: ANDA040001
- Marketing authorisation holder: ANI PHARMS
- Local brand name: METHAZOLAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 June 1993
- Application: ANDA040036
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: METHAZOLAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 January 1994
- Application: ANDA040062
- Marketing authorisation holder: ANDA REPOSITORY
- Local brand name: METHAZOLAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 August 1996
- Application: ANDA040102
- Marketing authorisation holder: POM PHARMA
- Local brand name: METHAZOLAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 July 1997
- Application: ANDA040011
- Marketing authorisation holder: APPLIED ANAL
- Local brand name: METHAZOLAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 October 2018
- Application: ANDA207438
- Marketing authorisation holder: BAUSCH AND LOMB INC
- Local brand name: METHAZOLAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 October 2022
- Application: ANDA215615
- Marketing authorisation holder: TAGI
- Local brand name: METHAZOLAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 February 2026
- Application: ANDA217408
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: METHAZOLAMIDE
- Indication: TABLET — ORAL
- Status: approved
Neptazane in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Ophthalmology approved in United States
Frequently asked questions
Is Neptazane approved in United States?
Yes. FDA authorised it on 26 January 1959; FDA authorised it on 26 January 1959; FDA authorised it on 30 June 1993.
Who is the marketing authorisation holder for Neptazane in United States?
LEDERLE holds the US marketing authorisation.