Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071717
Company: RISING PHARMA
Company: RISING PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLURAZEPAM HYDROCHLORIDE | FLURAZEPAM HYDROCHLORIDE | 30MG | CAPSULE;ORAL | Discontinued | None | No | No |
FLURAZEPAM HYDROCHLORIDE | FLURAZEPAM HYDROCHLORIDE | 15MG | CAPSULE;ORAL | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
07/31/1991 | 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 |
---|---|---|---|---|---|
12/16/2016 | SUPPL-4 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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01/24/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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08/25/1993 | SUPPL-1 | Labeling |
Label is not available on this site. |