Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020068
Company: CLINIGEN HLTHCARE
Company: CLINIGEN HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FOSCAVIR | FOSCARNET SODIUM | 2.4GM/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 09/27/1991 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/28/2020 | SUPPL-25 | Manufacturing (CMC)-Manufacturing Process |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020068Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020068Orig1s025ltr.pdf | |
| 02/24/2017 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020068s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020068Orig1s023ltr.pdf | |
| 11/10/2016 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020068s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020068Orig1s022ltr.pdf | |
| 05/29/2015 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/07/2014 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020068s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020068Orig1s020ltr.pdf | |
| 06/10/2014 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/10/2012 | SUPPL-18 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020068s018lbl.pdf | |
| 11/27/2007 | SUPPL-17 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020068s017lbl.pdf | |
| 05/15/2006 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020068s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020068s016LTR.pdf | |
| 06/13/2000 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 06/13/2000 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 11/16/1998 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/03/1997 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/31/1997 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 01/24/1997 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 01/24/1997 | SUPPL-7 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 01/24/1997 | SUPPL-6 | Efficacy-New Indication |
Label is not available on this site. |
||
| 11/17/1995 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 06/16/1995 | SUPPL-3 | Efficacy-New Indication |
Label is not available on this site. |
||
| 12/12/1995 | SUPPL-2 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/28/2020 | SUPPL-25 | Manufacturing (CMC)-Manufacturing Process | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020068Orig1s025lbl.pdf | |
| 02/24/2017 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020068s023lbl.pdf | |
| 11/10/2016 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020068s022lbl.pdf | |
| 11/07/2014 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020068s020lbl.pdf | |
| 02/10/2012 | SUPPL-18 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020068s018lbl.pdf |
| 11/27/2007 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020068s017lbl.pdf | |
| 05/15/2006 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020068s016lbl.pdf |
FOSCAVIR
INJECTABLE;INJECTION; 2.4GM/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FOSCARNET SODIUM | FOSCARNET SODIUM | 2.4GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 216602 | AMNEAL |
| FOSCARNET SODIUM | FOSCARNET SODIUM | 2.4GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 213807 | AVET LIFESCIENCES |
| FOSCARNET SODIUM | FOSCARNET SODIUM | 2.4GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 213987 | BEIJING |
| FOSCARNET SODIUM | FOSCARNET SODIUM | 2.4GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 212483 | FRESENIUS KABI USA |
| FOSCARNET SODIUM | FOSCARNET SODIUM | 2.4GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 213001 | GLAND PHARMA LTD |
| FOSCAVIR | FOSCARNET SODIUM | 2.4GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020068 | CLINIGEN HLTHCARE |