Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075999
Company: RISING PHARMA
Company: RISING PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LISINOPRIL | LISINOPRIL | 2.5MG | TABLET;ORAL | Discontinued | None | No | No |
LISINOPRIL | LISINOPRIL | 5MG | TABLET;ORAL | Discontinued | None | No | No |
LISINOPRIL | LISINOPRIL | 10MG | TABLET;ORAL | Discontinued | None | No | No |
LISINOPRIL | LISINOPRIL | 20MG | TABLET;ORAL | Discontinued | None | No | No |
LISINOPRIL | LISINOPRIL | 30MG | TABLET;ORAL | Discontinued | None | No | No |
LISINOPRIL | LISINOPRIL | 40MG | 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 |
---|---|---|---|---|---|---|---|
07/01/2002 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75999ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/08/2016 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
09/08/2016 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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04/13/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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04/13/2015 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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02/20/2013 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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03/25/2003 | SUPPL-4 | Labeling |
Label is not available on this site. |
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01/17/2003 | SUPPL-1 | Labeling |
Label is not available on this site. |