Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078185
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GALANTAMINE HYDROBROMIDE | GALANTAMINE HYDROBROMIDE | 4MG/ML | SOLUTION;ORAL | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
01/30/2009 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078185s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078185s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/02/2023 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
07/17/2018 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
07/17/2018 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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11/17/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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11/17/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
11/17/2015 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/30/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078185s000lbl.pdf |