Ganciclovir Injectable Solution
- Brand(s)
- Cytovene
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Genentech, Inc. (2010-08-03)
- Oldest Current Product
- 1989-06-23
- License(s)
- NDA, ANDA
- RxNORM
- INJECTABLE SOLUTION\GANCICLOVIR
- FDAOB
- INJECTION\INJECTION\GANCICLOVIR SODIUM\rdfq
- SPL Active
- INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\GANCICLOVIR SODIUM
- SPL Moiety
- INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\GANCICLOVIR
product(s) by strength(s)
ganciclovir 50 mg/ml injectable solution
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|
| 1 | 000046940 | Cytovene | NDA | Genentech, Inc. | 1989-06-23 | GANCICLOVIR SODIUM | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA019661 | 38e8f819-985c-4d20-aafd-3ba953af26ca |
| # | id | title | deprecated | applicant | approved | approved drug |
|---|
| 1 | ANDA076222 | GANCICLOVIR SODIUM | True | EUROHEALTH INTERNATIONAL SARL | 2003-07-16 | ANDA076222_001 |
| 2 | ANDA090658 | GANCICLOVIR | | FRESENIUS KABI USA LLC | 2010-06-21 | ANDA090658_001 |
| 3 | ANDA202624 | GANCICLOVIR | | LUITPOLD PHARMACEUTICALS INC | 2013-09-18 | ANDA202624_001 |
| 4 | NDA019661 | CYTOVENE | | ROCHE PALO ALTO LLC | 1989-06-23 | NDA019661_001 |
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|
| 1 | ANDA076222_001 | discontinued | GANCICLOVIR SODIUM (EQ 500MG BASE/VIAL) | INJECTION | False | | 2003-07-16 | GANCICLOVIR SODIUM |
| 2 | ANDA090658_001 | RX | GANCICLOVIR SODIUM (EQ 500MG BASE/VIAL) | INJECTION | False | AP | 2010-06-21 | GANCICLOVIR |
| 3 | ANDA202624_001 | RX | GANCICLOVIR SODIUM (EQ 500MG BASE/VIAL) | INJECTION | False | AP | 2013-09-18 | GANCICLOVIR |
| 4 | NDA019661_001 | RX | GANCICLOVIR SODIUM (EQ 500MG BASE/VIAL) | INJECTION | True | AP | 1989-06-23 | CYTOVENE |
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|
| 1 | 35addab5-09db-4f8a-9c69-6fbce33ecc37 (view SPL) | | prescription | Human Prescription | App Pharmaceuticals, Llc | MANUFACTURE | 2014-04-03 | 2 | 633230315 |
| 2 | 38e8f819-985c-4d20-aafd-3ba953af26ca (view SPL) | CYTOVENE-IV (ganciclovir sodium for injection) | prescription | Human Prescription | Genentech, Inc. | API MANUFACTURE, MANUFACTURE | 2010-08-03 | 6 | 000046940 |
| 3 | b47f5d1c-36b8-49b6-a410-3b3f4661dde7 (view SPL) | | prescription | Human Prescription | App Pharmaceuticals, Llc | MANUFACTURE | 2010-06-30 | 1 | 633230315 |