Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077842
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | EQ 1MG BASE | TABLET;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 |
---|---|---|---|---|---|---|---|
12/31/2007 | 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 |
---|---|---|---|---|---|
08/12/2022 | SUPPL-14 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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09/18/2014 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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06/07/2010 | SUPPL-6 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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11/04/2014 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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11/24/2008 | SUPPL-1 | Labeling |
Label is not available on this site. |