Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076437
Company: DR REDDYS LABS LTD
Company: DR REDDYS LABS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FINASTERIDE | FINASTERIDE | 5MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/28/2007 | 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 |
|---|---|---|---|---|---|
| 06/17/2025 | SUPPL-10 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 09/28/2012 | SUPPL-8 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/29/2012 | SUPPL-6 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 08/03/2011 | SUPPL-5 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 03/01/2011 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/27/2010 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
FINASTERIDE
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FINASTERIDE | FINASTERIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 090121 | ACCORD HLTHCARE |
| FINASTERIDE | FINASTERIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 204304 | ALKEM LABS LTD |
| FINASTERIDE | FINASTERIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 078341 | AUROBINDO PHARMA |
| FINASTERIDE | FINASTERIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 076437 | DR REDDYS LABS LTD |
| FINASTERIDE | FINASTERIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 090061 | HETERO LABS LTD III |
| FINASTERIDE | FINASTERIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 090507 | SUN PHARM |
| FINASTERIDE | FINASTERIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 076511 | TEVA |
| FINASTERIDE | FINASTERIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 078900 | ZYDUS PHARMS USA INC |
| PROSCAR | FINASTERIDE | 5MG | TABLET;ORAL | Prescription | Yes | AB | 020180 | ORGANON |