Drugs@FDA: FDA-Approved Drugs
Company: BOEHRINGER INGELHEIM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PERSANTINE | DIPYRIDAMOLE | 25MG | TABLET;ORAL | Discontinued | None | Yes | No |
PERSANTINE | DIPYRIDAMOLE | 50MG | TABLET;ORAL | Discontinued | None | Yes | No |
PERSANTINE | DIPYRIDAMOLE | 75MG | TABLET;ORAL | Discontinued | None | Yes | 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 |
---|---|---|---|---|---|---|---|
12/06/1961 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/11/2019 | SUPPL-61 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/012836s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/012836Orig1s061ltr.pdf | |
07/29/2015 | SUPPL-60 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/08/2014 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/01/2005 | SUPPL-57 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/012836s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/012836s057ltr.pdf | |
06/20/2002 | SUPPL-56 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/08/2002 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/05/2004 | SUPPL-54 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/12836s054ltr.pdf |
05/24/2001 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/08/2000 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/03/1997 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
05/18/1994 | SUPPL-50 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
02/18/1994 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
03/26/1991 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
02/21/1995 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/08/1988 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
08/30/1989 | SUPPL-44 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
12/12/1988 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/24/1988 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
02/06/1987 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/22/1986 | SUPPL-38 | Labeling |
Label is not available on this site. |
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10/08/1982 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/22/1986 | SUPPL-14 | Efficacy-New Indication |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/11/2019 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/012836s061lbl.pdf | |
08/01/2005 | SUPPL-57 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/012836s057lbl.pdf |