Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203988
Company: EUGIA PHARMA
Company: EUGIA PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) | SOLUTION;INTRAVENOUS | 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 |
---|---|---|---|---|---|---|---|
04/01/2015 | 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 |
---|---|---|---|---|---|
10/22/2020 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
11/19/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
SILDENAFIL CITRATE
SOLUTION;INTRAVENOUS; EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
REVATIO | SILDENAFIL CITRATE | EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 022473 | VIATRIS |
SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 203988 | EUGIA PHARMA |