Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202025
Company: AMNEAL PHARMS
Company: AMNEAL PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 20MG 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 |
|---|---|---|---|---|---|---|---|
| 02/28/2013 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/15/2020 | SUPPL-4 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 01/15/2020 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 10/17/2016 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/18/2015 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
SILDENAFIL CITRATE
TABLET;ORAL; EQ 20MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| REVATIO | SILDENAFIL CITRATE | EQ 20MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021845 | VIATRIS |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 210394 | AJANTA PHARMA LTD |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 202025 | AMNEAL PHARMS |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 203963 | AUROBINDO PHARMA LTD |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 202598 | CHARTWELL RX |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 203623 | HETERO LABS LTD V |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 203814 | MACLEODS PHARMS LTD |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 204883 | RUBICON |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 078380 | TEVA PHARMS |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 091479 | TORRENT PHARMS LTD |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 202503 | WATSON LABS INC |