Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040733
Company: RISING
Company: RISING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DIPYRIDAMOLE | DIPYRIDAMOLE | 25MG | TABLET;ORAL | Prescription | AB | No | No |
DIPYRIDAMOLE | DIPYRIDAMOLE | 50MG | TABLET;ORAL | Prescription | AB | No | No |
DIPYRIDAMOLE | DIPYRIDAMOLE | 75MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
02/13/2007 | 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 |
---|---|---|---|---|---|
02/02/2021 | SUPPL-6 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
11/30/2016 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
DIPYRIDAMOLE
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 |
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 |
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 |