| These highlights do not include all the information needed to use VALGANCICLOVIR TABLETS safely and effectively. See full prescribing information for VALGANCICLOVIR TABLETS. VALGANCICLOVIR tablets, for oral use Initial U.S. Approval: 2001 | Dr. Reddy's Laboratories Limited | Dr. Reddy's Laboratories Limited - FTO 3 | 20260601 | 11 |
| These highlights do not include all the information needed to use ZIRGAN® safely and effectively. See full prescribing information for ZIRGAN. ZIRGAN (ganciclovir ophthalmic gel) 0.15%, for topical ophthalmic use Initial U.S. approval: 1989 | Bausch & Lomb Incorporated | 20260518 | 15 |
| HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VALGANCICLOVIR TABLETS safely and effectively. See full prescribing information for VALGANCICLOVIR TABLETS. VALGANCICLOVIR tablets, for oral use Initial U.S. Approval: 2001 | Major Pharmaceuticals | 20260326 | 6 |
| These highlights do not include all the information needed to use VALGANCICLOVIR FOR ORAL SOLUTION safely and effectively. See full prescribing information for VALGANCICLOVIR FOR ORAL SOLUTION. VALGANCICLOVIR for oral solution Initial U.S. Approval: 2001 | Micro Labs Limited | 20260323 | 1 |
| These highlights do not include all the information needed to use VALGANCICLOVIR TABLETS safely and effectively. See full prescribing information for VALGANCICLOVIR TABLETS. VALGANCICLOVIR tablets, for oral use Initial U.S. Approval: 2001 | NorthStar Rx LLC | Aurobindo Pharma Limited | 20260120 | 1 |
| Valganciclovir for Oral Solution Rx Only These highlights do not include all the information needed to use VALGANCICLOVIR FOR ORAL SOLUTION safely and effectively. See full prescribing information for VALGANCICLOVIR FOR ORAL SOLUTION. Initial U.S. Approval: 2001 | AvKARE | 20260119 | 2 |
| Valganciclovir Tablet, USP Rx only These highlights do not include all the information needed to use VALGANCICLOVIR TABLETS safely and effectively. See full prescribing information for VALGANCICLOVIR TABLETS. VALGANCICLOVIR tablets, for oral use Initial U.S. Approval: 2001 | AvKARE | 20260119 | 2 |
| These highlights do not include all the information needed to use GANCICLOVIR FOR INJECTION safely and effectively. See full prescribing information for GANCICLOVIR FOR INJECTION. GANCICLOVIR FOR INJECTION, for intravenous use Initial U.S. Approval: 1989 Rx only | Fresenius Kabi USA, LLC | 20260109 | 6 |
| These highlights do not include all the information needed to use GANCICLOVIR FOR INJECTION safely and effectively. See full prescribing information for GANCICLOVIR FOR INJECTION. GANCICLOVIR FOR INJECTION, for intravenous use Initial U.S. Approval: 1989 Rx only | Fresenius Kabi USA, LLC | 20260109 | 8 |
| These highlights do not include all the information needed to use VALGANCICLOVIR TABLETS safely and effectively. See full prescribing information for VALGANCICLOVIR TABLETS. VALGANCICLOVIR tablets, for oral use Initial U.S. Approval: 2001 | Aurobindo Pharma Limited | 20260106 | 12 |
| Valganciclovir Tablet, USP HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VALGANCICLOVIR TABLETS safely and effectively. See full prescribing information for VALGANCICLOVIR TABLETS. VALGANCICLOVIR Tablets USP, for oral use Initial U.S. Approval: 2001 | AvPAK | 20251231 | 6 |
| These highlights do not include all the information needed to use VALGANCICLOVIR FOR ORAL SOLUTION safely and effectively. See full prescribing information for VALGANCICLOVIR FOR ORAL SOLUTION. VALGANCICLOVIR for oral solution Initial U.S. Approval: 2001 | Aurobindo Pharma Limited | 20251224 | 3 |
| These highlights do not include all the information needed to use VALCYTE ® safely and effectively. See full prescribing information for VALCYTE. VALCYTE (valganciclovir) tablets, for oral use VALCYTE (valganciclovir) for oral solution Initial U.S. Approval: 2001 | H2-Pharma, LLC | CHEPLAPHARM Arzneimittel GmbH | 20251208 | 24 |
| These highlights do not include all the information needed to use VALGANCICLOVIR FOR ORAL SOLUTION safely and effectively. See full prescribing information for VALGANCICLOVIR FOR ORAL SOLUTION. VALGANCICLOVIR for oral solution Initial U.S. Approval: 2001 | Ajanta Pharma USA Inc. | Ajanta Pharma Limited, Paithan | Ajanta Pharma Ltd., Dahej | 20251130 | 9 |
| These highlights do not include all the information needed to use VALGANCICLOVIR TABLETS safely and effectively. See full prescribing information for VALGANCICLOVIR TABLETS. VALGANCICLOVIR tablets, for oral use Initial U.S. Approval: 2001 | Ajanta Pharma USA Inc. | Ajanta Pharma Limited, Paithan | Ajanta Pharma Ltd., Dahej | 20251130 | 8 |
| These highlights do not include all the information needed to use VALGANCICLOVIR FOR ORAL SOLUTION safely and effectively. See full prescribing information for VALGANCICLOVIR FOR ORAL SOLUTION. VALGANCICLOVIR for oral solution Initial U.S. Approval: 2001 | Actavis Pharma, Inc. | 20250627 | 24 |
| These highlights do not include all the information needed to use VALGANCICLOVIR TABLETS safely and effectively. See full prescribing information for VALGANCICLOVIR TABLETS. VALGANCICLOVIR tablets, for oral use Initial U.S. Approval: 2001 | Strides Pharma Science Limited | Strides Pharma Global Pte. Ltd. | 20250319 | 2 |
| These highlights do not include all the information needed to use GANCICLOVIR FOR INJECTION safely and effectively. See full prescribing information for GANCICLOVIR FOR INJECTION. GANCICLOVIR for injection, for intravenous use Initial U.S. Approval: 1989 | Hikma Pharmaceuticals USA Inc. | 20250207 | 7 |
| These highlights do not include all the information needed to use GANCICLOVIR for Injection, USP safely and effectively. See full prescribing information for GANCICLOVIR for Injection, USP. GANCICLOVIR for Injection, USP for intravenous use Initial U.S. Approval: 1989 | Slate Run Pharmaceuticals, LLC | Hainan Poly Pharm. Co., Ltd. | 20250122 | 3 |
| HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VALGANCICLOVIR TABLETS safely and effectively. See full prescribing information for VALGANCICLOVIR TABLETS. VALGANCICLOVIR tablets, for oral use Initial U.S. Approval: 2001 | Camber Pharmaceuticals, Inc. | Hetero Labs Limited Unit V | 20250109 | 5 |
| These highlights do not include all the information needed to use GANCICLOVIR for Injection, USP safely and effectively. See full prescribing information for GANCICLOVIR for Injection, USP. GANCICLOVIR for Injection, USP for intravenous use Initial U.S. Approval: 1989 | Slate Run Pharmaceuticals, LLC | Hainan Poly Pharm. Co., Ltd. | 20250102 | 2 |
| These highlights do not include all the information needed to use VALGANCICLOVIR TABLETS safely and effectively. See full prescribing information for VALGANCICLOVIR TABLETS. VALGANCICLOVIR tablets, for oral use Initial U.S. Approval: 2001 | American Health Packaging | 20240923 | 7 |
| These highlights do not include all the information needed to use VALGANCICLOVIR FOR ORAL SOLUTION safely and effectively. See full prescribing information for VALGANCICLOVIR FOR ORAL SOLUTION. VALGANCICLOVIR for oral solution Initial U.S. Approval: 2001 | NorthStar RxLLC | Annora Pharma Private Limited | 20240411 | 1 |
| VALGANCICLOVIR TABLETS. These highlights do not include all the information needed to use VALGANCICLOVIR TABLETS safely and effectively. See full prescribing information for VALGANCICLOVIR TABLETS. VALGANCICLOVIR tablets, for oral use Initial U.S. Approval: 2001 | Golden State Medical Supply, Inc. | 20240228 | 5 |
| These highlights do not include all the information needed to use VALGANCICLOVIR TABLETS safely and effectively. See full prescribing information for VALGANCICLOVIR TABLETS. VALGANCICLOVIR tablets, for oral use Initial U.S. Approval: 2001 | Strides Pharma Science Limited | Strides Pharma Global Pte. Ltd. | Strides Pharma, Inc | 20240126 | 3 |
| These highlights do not include all the information needed to use VALGANCICLOVIR FOR ORAL SOLUTION safely and effectively. See full prescribing information for VALGANCICLOVIR FOR ORAL SOLUTION. VALGANCICLOVIR for oral solution Initial U.S. Approval: 2001 | American Health Packaging | 20230822 | 1 |
| These highlights do not include all the information needed to use VALGANCICLOVIR FOR ORAL SOLUTION safely and effectively. See full prescribing information for VALGANCICLOVIR FOR ORAL SOLUTION. VALGANCICLOVIR for oral solution Initial U.S. Approval: 2001 | Florida Pharmaceutical Products, LLC | Appco Pharma LLC | 20230713 | 1 |
| These highlights do not include all the information needed to use VALGANCICLOVIR TABLETS safely and effectively. See full prescribing information for VALGANCICLOVIR TABLETS . VALGANCICLOVIR tablets , for oral use Initial U.S. Approval: 2001 | Dr. Reddy's Laboratories Inc | DR. REDDY'S LABORATORIES LIMITED (FTO-Sez-Process Unit-01) | 20221223 | 11 |
| These highlights do not include all the information needed to use GANCICLOVIR INJECTION safely and effectively. See full prescribing information for GANCICLOVIR INJECTION. GANCICLOVIR injection, for intravenous use Initial U.S. Approval: 1989 | Pharmascience Inc. | 20221221 | 9 |
| These highlights do not include all the information needed to use VALGANCICLOVIR FOR ORAL SOLUTION safely and effectively. See full prescribing information for VALGANCICLOVIR FOR ORAL SOLUTION. VALGANCICLOVIR for oral solution Initial U.S. Approval: 2001 | Camber Pharmaceuticals, Inc. | Annora Pharma Private Limited | 20221010 | 1 |
| These highlights do not include all the information needed to use VALGANCICLOVIR FOR ORAL SOLUTION safely and effectively. See full prescribing information for VALGANCICLOVIR FOR ORAL SOLUTION. VALGANCICLOVIR for oral solution Initial U.S. Approval: 2001 | airis PHARMA PVT LTD | 20220303 | 1 |
| These highlights do not include all the information needed to use VALGANCICLOVIR FOR ORAL SOLUTION safely and effectively. See full prescribing information for VALGANCICLOVIR FOR ORAL SOLUTION. VALGANCICLOVIR for oral solution Initial U.S. Approval: 2001 | Novadoz Pharmaceuticals LLC | MSN Pharmaceuticals Inc. | 20220129 | 1 |
| These highlights do not include all the information needed to use GANCICLOVIR FOR INJECTION safely and effectively. See full prescribing information for GANCICLOVIR FOR INJECTION. GANCICLOVIR for injection, for intravenous use Initial U.S. Approval: 1989 | Endo USA, Inc. | 20201224 | 7 |
| These highlights do not include all the information needed to use GANCICLOVIR INJECTION safely and effectively. See full prescribing information for GANCICLOVIR INJECTION. GANCICLOVIR injection, for intravenous use Initial U.S. Approval: 1989 | Sagent Pharmaceuticals | 20201130 | 5 |
| These highlights do not include all the information needed to use GANCICLOVIR for Injection, USP safely and effectively. See full prescribing information for GANCICLOVIR for Injection, USP. GANCICLOVIR for Injection, USP for intravenous use Initial U.S. Approval: 1989 | Hainan Poly Pharm. Co., Ltd. | 20190130 | 2 |
| These highlights do not include all the information needed to use GANCICLOVIR INJECTION safely and effectively. See full prescribing information for GANCICLOVIR INJECTION. GANCICLOVIR INJECTION, for intravenous use Initial U.S. Approval: 1989 | EXELA PHARMA SCIENCES, LLC | 20171006 | 3 |
| GANCICLOVIR CAPSULES Rx only FOR ORAL ADMINISTRATION | Ranbaxy Pharmaceuticals Inc. | Ranbaxy Laboratories Limited | 20111020 | 1 |