Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210687
Company: MSN
Company: MSN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SILODOSIN | SILODOSIN | 4MG | CAPSULE;ORAL | Prescription | AB | No | No |
| SILODOSIN | SILODOSIN | 8MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 12/03/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/24/2022 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
SILODOSIN
CAPSULE;ORAL; 4MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RAPAFLO | SILODOSIN | 4MG | CAPSULE;ORAL | Prescription | Yes | AB | 022206 | ABBVIE |
| SILODOSIN | SILODOSIN | 4MG | CAPSULE;ORAL | Prescription | No | AB | 211060 | AJANTA PHARMA LTD |
| SILODOSIN | SILODOSIN | 4MG | CAPSULE;ORAL | Prescription | No | AB | 209745 | AMNEAL PHARMS CO |
| SILODOSIN | SILODOSIN | 4MG | CAPSULE;ORAL | Prescription | No | AB | 210626 | AUROBINDO PHARMA LTD |
| SILODOSIN | SILODOSIN | 4MG | CAPSULE;ORAL | Prescription | No | AB | 204726 | CHARTWELL RX |
| SILODOSIN | SILODOSIN | 4MG | CAPSULE;ORAL | Prescription | No | AB | 213230 | CREEKWOOD PHARMS |
| SILODOSIN | SILODOSIN | 4MG | CAPSULE;ORAL | Prescription | No | AB | 204793 | HETERO LABS LTD V |
| SILODOSIN | SILODOSIN | 4MG | CAPSULE;ORAL | Prescription | No | AB | 206541 | LUPIN LTD |
| SILODOSIN | SILODOSIN | 4MG | CAPSULE;ORAL | Prescription | No | AB | 211166 | MACLEODS PHARMS LTD |
| SILODOSIN | SILODOSIN | 4MG | CAPSULE;ORAL | Prescription | No | AB | 210687 | MSN |
| SILODOSIN | SILODOSIN | 4MG | CAPSULE;ORAL | Prescription | No | AB | 209029 | PRINSTON INC |
CAPSULE;ORAL; 8MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RAPAFLO | SILODOSIN | 8MG | CAPSULE;ORAL | Prescription | Yes | AB | 022206 | ABBVIE |
| SILODOSIN | SILODOSIN | 8MG | CAPSULE;ORAL | Prescription | No | AB | 211060 | AJANTA PHARMA LTD |
| SILODOSIN | SILODOSIN | 8MG | CAPSULE;ORAL | Prescription | No | AB | 209745 | AMNEAL PHARMS CO |
| SILODOSIN | SILODOSIN | 8MG | CAPSULE;ORAL | Prescription | No | AB | 210626 | AUROBINDO PHARMA LTD |
| SILODOSIN | SILODOSIN | 8MG | CAPSULE;ORAL | Prescription | No | AB | 204726 | CHARTWELL RX |
| SILODOSIN | SILODOSIN | 8MG | CAPSULE;ORAL | Prescription | No | AB | 213230 | CREEKWOOD PHARMS |
| SILODOSIN | SILODOSIN | 8MG | CAPSULE;ORAL | Prescription | No | AB | 204793 | HETERO LABS LTD V |
| SILODOSIN | SILODOSIN | 8MG | CAPSULE;ORAL | Prescription | No | AB | 206541 | LUPIN LTD |
| SILODOSIN | SILODOSIN | 8MG | CAPSULE;ORAL | Prescription | No | AB | 211166 | MACLEODS PHARMS LTD |
| SILODOSIN | SILODOSIN | 8MG | CAPSULE;ORAL | Prescription | No | AB | 210687 | MSN |
| SILODOSIN | SILODOSIN | 8MG | CAPSULE;ORAL | Prescription | No | AB | 209029 | PRINSTON INC |