Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204024
Company: SUN PHARM
Company: SUN PHARM
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 | 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 |
---|---|---|---|---|---|---|---|
11/20/2019 | 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 |
---|---|---|---|---|---|
04/22/2025 | SUPPL-9 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert |
Label is not available on this site. |
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 |