FDA — authorised 3 July 1968
- Marketing authorisation holder: MONARCH PHARMS
- Status: approved
🇺🇸 Gramoderm in United States
FDA authorised Gramoderm on 3 July 1968
Marketing authorisations
FDA — authorised 31 January 1996
- Application: ANDA064047
- Marketing authorisation holder: BAUSCH AND LOMB
- Local brand name: NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA060427
- Marketing authorisation holder: DOW PHARM
- Local brand name: NEO-POLYCIN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA062383
- Marketing authorisation holder: PHARMAFAIR
- Local brand name: NEOMYCIN SULFATE AND POLYMYXIN B SULFATE GRAMICIDIN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA062788
- Marketing authorisation holder: WATSON LABS
- Local brand name: NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
Gramoderm 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 Gramoderm approved in United States?
Yes. FDA authorised it on 3 July 1968; FDA authorised it on 31 January 1996; FDA has authorised it.
Who is the marketing authorisation holder for Gramoderm in United States?
MONARCH PHARMS holds the US marketing authorisation.