Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074930
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ACYCLOVIR SODIUM | ACYCLOVIR SODIUM | EQ 50MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/13/1998 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74930ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74930ap.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/28/2024 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
01/20/2005 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
05/24/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
05/10/2000 | SUPPL-1 | Labeling |
Label is not available on this site. |
ACYCLOVIR SODIUM
INJECTABLE;INJECTION; EQ 50MG BASE/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ACYCLOVIR SODIUM | ACYCLOVIR SODIUM | EQ 50MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203701 | EUGIA PHARMA |
ACYCLOVIR SODIUM | ACYCLOVIR SODIUM | EQ 50MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074930 | FRESENIUS KABI USA |
ACYCLOVIR SODIUM | ACYCLOVIR SODIUM | EQ 50MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215404 | FRESENIUS KABI USA |
ACYCLOVIR SODIUM | ACYCLOVIR SODIUM | EQ 50MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 218111 | SLATE RUN PHARMA |
ACYCLOVIR SODIUM | ACYCLOVIR SODIUM | EQ 50MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206535 | ZYDUS PHARMS |