FDA Orange Book · active-ingredient family
Ganciclovir
Ganciclovir is approved as 4 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:GANZYK-RTU · NDA 209347
4
Brand (NDA)
1
Generics (ANDA)
1
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, gel, implant, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GANZYK-RTURLD | EXELA PHARMA | NDA 209347 | — | Feb 17, 2017 | |
| ZIRGANRLD | BAUSCH AND LOMB | NDA 022211 | — | Sep 15, 2009 | |
| CYTOVENERLD×2 | ROCHE PALO | NDA 020460 | — | Dec 22, 1994 | |
| VITRASERT | BAUSCH AND LOMB | NDA 020569 | — | Mar 04, 1996 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GANCICLOVIR×2 | RANBAXY LABS LTD | ANDA 076457 | — | Jun 27, 2003 |
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9486530 | Sep 02, 2034 | in 8 yr 4 mo | Product |
Ganciclovir — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
