Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071826
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MINOXIDIL | MINOXIDIL | 2.5MG | 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 |
---|---|---|---|---|---|---|---|
11/14/1988 | 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 |
---|---|---|---|---|---|
04/09/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
04/09/2015 | SUPPL-9 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
11/21/2003 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
11/26/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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11/26/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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04/02/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/08/1993 | SUPPL-1 | Labeling |
Label is not available on this site. |
MINOXIDIL
TABLET;ORAL; 2.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MINOXIDIL | MINOXIDIL | 2.5MG | TABLET;ORAL | Prescription | No | AB | 071826 | ENDO OPERATIONS |
MINOXIDIL | MINOXIDIL | 2.5MG | TABLET;ORAL | Prescription | No | AB | 072709 | SUN PHARM INDUSTRIES |
MINOXIDIL | MINOXIDIL | 2.5MG | TABLET;ORAL | Prescription | No | AB | 071344 | WATSON LABS |