Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207750
Company: ALKEM LABS LTD
Company: ALKEM LABS LTD
| 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 |
|---|---|---|---|---|---|---|---|
| 01/06/2017 | ORIG-1 | Approval | STANDARD |
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 | 077335 | CIPLA |
| 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 | MERCK |
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