Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090072
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PERINDOPRIL ERBUMINE | PERINDOPRIL ERBUMINE | 2MG | TABLET;ORAL | Discontinued | None | No | No |
PERINDOPRIL ERBUMINE | PERINDOPRIL ERBUMINE | 4MG | TABLET;ORAL | Discontinued | None | No | No |
PERINDOPRIL ERBUMINE | PERINDOPRIL ERBUMINE | 8MG | 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 |
---|---|---|---|---|---|---|---|
11/10/2009 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090072s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/27/2024 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
11/09/2016 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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05/04/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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05/04/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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05/04/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
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02/18/2011 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |