Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204304
Company: ALKEM LABS LTD
Company: ALKEM 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 |
---|---|---|---|---|---|---|---|
01/05/2017 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204304Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/17/2023 | SUPPL-11 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
01/17/2023 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
01/17/2023 | SUPPL-8 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
03/08/2017 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide |
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 |