FDA — authorised 28 July 1988
- Application: NDA019201
- Marketing authorisation holder: NOVARTIS
- Local brand name: VOLTAREN
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
🇺🇸 1% Diclofenac Topical Gel in United States
FDA authorised 1% Diclofenac Topical Gel on 28 July 1988
Marketing authorisations
FDA — authorised 28 March 1991
- Application: NDA020037
- Marketing authorisation holder: NOVARTIS
- Local brand name: VOLTAREN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA
- Status: approved
1% Diclofenac Topical Gel 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 1% Diclofenac Topical Gel approved in United States?
Yes. FDA authorised it on 28 July 1988; FDA authorised it on 28 March 1991; FDA has authorised it.
Who is the marketing authorisation holder for 1% Diclofenac Topical Gel in United States?
NOVARTIS holds the US marketing authorisation.