Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012836
Company: BOEHRINGER INGELHEIM
Company: BOEHRINGER INGELHEIM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PERSANTINE | DIPYRIDAMOLE | 25MG | TABLET;ORAL | Prescription | AB | Yes | No |
| PERSANTINE | DIPYRIDAMOLE | 50MG | TABLET;ORAL | Prescription | AB | Yes | No |
| PERSANTINE | DIPYRIDAMOLE | 75MG | TABLET;ORAL | Prescription | AB | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 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. |
||
| 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 |
PERSANTINE
TABLET;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DIPYRIDAMOLE | DIPYRIDAMOLE | 25MG | TABLET;ORAL | Prescription | No | AB | 087184 | BARR |
| DIPYRIDAMOLE | DIPYRIDAMOLE | 25MG | TABLET;ORAL | Prescription | No | AB | 040782 | IMPAX LABS |
| DIPYRIDAMOLE | DIPYRIDAMOLE | 25MG | TABLET;ORAL | Prescription | No | AB | 040542 | OXFORD PHARMS |
| DIPYRIDAMOLE | DIPYRIDAMOLE | 25MG | TABLET;ORAL | Prescription | No | AB | 040733 | RISING |
| DIPYRIDAMOLE | DIPYRIDAMOLE | 25MG | TABLET;ORAL | Prescription | No | AB | 040874 | ZYDUS PHARMS USA INC |
| PERSANTINE | DIPYRIDAMOLE | 25MG | TABLET;ORAL | Prescription | Yes | AB | 012836 | BOEHRINGER INGELHEIM |
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DIPYRIDAMOLE | DIPYRIDAMOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 087716 | BARR |
| DIPYRIDAMOLE | DIPYRIDAMOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 040782 | IMPAX LABS |
| DIPYRIDAMOLE | DIPYRIDAMOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 040542 | OXFORD PHARMS |
| DIPYRIDAMOLE | DIPYRIDAMOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 040733 | RISING |
| DIPYRIDAMOLE | DIPYRIDAMOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 040874 | ZYDUS PHARMS USA INC |
| PERSANTINE | DIPYRIDAMOLE | 50MG | TABLET;ORAL | Prescription | Yes | AB | 012836 | BOEHRINGER INGELHEIM |
TABLET;ORAL; 75MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DIPYRIDAMOLE | DIPYRIDAMOLE | 75MG | TABLET;ORAL | Prescription | No | AB | 087717 | BARR |
| DIPYRIDAMOLE | DIPYRIDAMOLE | 75MG | TABLET;ORAL | Prescription | No | AB | 040782 | IMPAX LABS |
| DIPYRIDAMOLE | DIPYRIDAMOLE | 75MG | TABLET;ORAL | Prescription | No | AB | 040542 | OXFORD PHARMS |
| DIPYRIDAMOLE | DIPYRIDAMOLE | 75MG | TABLET;ORAL | Prescription | No | AB | 040733 | RISING |
| DIPYRIDAMOLE | DIPYRIDAMOLE | 75MG | TABLET;ORAL | Prescription | No | AB | 040874 | ZYDUS PHARMS USA INC |
| PERSANTINE | DIPYRIDAMOLE | 75MG | TABLET;ORAL | Prescription | Yes | AB | 012836 | BOEHRINGER INGELHEIM |