Ganciclovir sodium
Ganciclovir sodium: 1 brand, 8 generics; first approved Jun 23, 1989; generic available.
Generic available: 8 ANDA applications approved.
Brand (NDA) products
- CYTOVENERLDCHEPLAPHARMNDA 0196611989
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued -
Generic (ANDA) products (8)
- GANCICLOVIR SODIUMCUSTOPHARM INCANDA 2120012019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued - - GANCICLOVIR SODIUMHAINAN POLYANDA 2042042018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP - GANCICLOVIR SODIUMRSPHARMASCIENCE INCANDA 2076452017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP - GANCICLOVIR SODIUMONESOURCE SPECIALTYANDA 2045602017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued - - GANCICLOVIR SODIUMPH HEALTHANDA 2049502016
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP - GANCICLOVIR SODIUMAM REGENTANDA 2026242013
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued - - GANCICLOVIR SODIUMFRESENIUS KABI USAANDA 0906582010
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP - GANCICLOVIR SODIUMHIKMAANDA 0762222003
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP
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.
Approval history
Approvals span 1989–2019 across 9 FDA applications.
Ganciclovir sodium: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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