Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090658
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GANCICLOVIR SODIUM | GANCICLOVIR SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
06/21/2010 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/08/2020 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
06/08/2020 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
GANCICLOVIR SODIUM
INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GANCICLOVIR SODIUM | GANCICLOVIR SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204950 | ENDO OPERATIONS |
GANCICLOVIR SODIUM | GANCICLOVIR SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090658 | FRESENIUS KABI USA |
GANCICLOVIR SODIUM | GANCICLOVIR SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 076222 | HIKMA |
GANCICLOVIR SODIUM | GANCICLOVIR SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 207645 | PHARMASCIENCE INC |
GANCICLOVIR SODIUM | GANCICLOVIR SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204204 | SLATE RUN PHARMA |