Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076436
Company: DR REDDYS LABS INC
Company: DR REDDYS LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FINASTERIDE | FINASTERIDE | 1MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/28/2006 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076436s000LTR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/21/2014 | SUPPL-7 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 09/28/2012 | SUPPL-6 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/27/2011 | SUPPL-4 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 08/25/2011 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/11/2011 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
FINASTERIDE
TABLET;ORAL; 1MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FINASTERIDE | FINASTERIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 091643 | ACCORD HLTHCARE |
| FINASTERIDE | FINASTERIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 207750 | ALKEM LABS LTD |
| FINASTERIDE | FINASTERIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 203687 | AUROBINDO PHARMA LTD |
| FINASTERIDE | FINASTERIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 076436 | DR REDDYS LABS INC |
| FINASTERIDE | FINASTERIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 090060 | HETERO LABS LTD III |
| FINASTERIDE | FINASTERIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 090508 | SUN PHARM |
| PROPECIA | FINASTERIDE | 1MG | TABLET;ORAL | Prescription | Yes | AB | 020788 | ORGANON |