Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040760
Company: HIKMA PHARMS
Company: HIKMA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | 200MG | 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 |
---|---|---|---|---|---|---|---|
08/15/2007 | 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 |
---|---|---|---|---|---|
03/21/2024 | SUPPL-11 | Labeling, Labeling-Package Insert |
Label is not available on this site. |
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03/21/2024 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
07/18/2022 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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10/20/2021 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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04/28/2020 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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04/01/2020 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040760Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/040760Orig1s006ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/01/2020 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/040760Orig1s006lbl.pdf |