FDA Orange Book · active-ingredient family
Ganciclovir sodium
Ganciclovir sodium is approved as 1 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CYTOVENE · NDA 019661
1
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CYTOVENERLD | CHEPLAPHARM | NDA 019661 | — | Jun 23, 1989 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GANCICLOVIR SODIUM | CUSTOPHARM INC | ANDA 212001 | — | Jun 20, 2019 | |
| GANCICLOVIR SODIUM | SLATE RUN PHARMA | ANDA 204204 | AP | Nov 08, 2018 | |
| GANCICLOVIR SODIUM | PHARMASCIENCE INC | ANDA 207645 | AP | Dec 08, 2017 | |
| GANCICLOVIR SODIUM | ONESOURCE SPECIALTY | ANDA 204560 | — | Nov 17, 2017 | |
| GANCICLOVIR SODIUM | PH HEALTH | ANDA 204950 | AP | Dec 06, 2016 | |
| GANCICLOVIR SODIUM | AM REGENT | ANDA 202624 | — | Sep 18, 2013 | |
| GANCICLOVIR SODIUM | FRESENIUS KABI USA | ANDA 090658 | AP | Jun 21, 2010 | |
| GANCICLOVIR SODIUM | HIKMA | ANDA 076222 | AP | Jul 16, 2003 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Ganciclovir sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
