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. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/10/2023 | SUPPL-9 | Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
10/10/2023 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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03/11/2022 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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03/11/2022 | SUPPL-1 | Labeling-Container/Carton Labels |
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 |