Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204060
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FOSAMPRENAVIR CALCIUM | FOSAMPRENAVIR CALCIUM | EQ 700MG BASE | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 04/15/2016 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204060Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/19/2021 | SUPPL-3 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 03/19/2021 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/15/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204060lbl.pdf |
FOSAMPRENAVIR CALCIUM
TABLET;ORAL; EQ 700MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FOSAMPRENAVIR CALCIUM | FOSAMPRENAVIR CALCIUM | EQ 700MG BASE | TABLET;ORAL | Prescription | No | AB | 204060 | MYLAN |
| FOSAMPRENAVIR CALCIUM | FOSAMPRENAVIR CALCIUM | EQ 700MG BASE | TABLET;ORAL | Prescription | No | AB | 204024 | SUN PHARM |