Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090061
Company: HETERO LABS LTD III
Company: HETERO LABS LTD III
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 |
---|---|---|---|---|---|---|---|
06/07/2010 | 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 |
---|---|---|---|---|---|
03/11/2022 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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03/11/2022 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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03/19/2015 | SUPPL-10 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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04/06/2015 | SUPPL-9 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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04/06/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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04/26/2013 | SUPPL-6 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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02/22/2013 | SUPPL-5 | Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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02/14/2012 | SUPPL-3 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
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12/22/2010 | SUPPL-1 | Labeling-Package Insert, Labeling-Patient 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 |