Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206753
Company: ZYDUS PHARMS
Company: ZYDUS PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ASPIRIN AND DIPYRIDAMOLE | ASPIRIN; DIPYRIDAMOLE | 25MG;200MG | CAPSULE, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
08/29/2017 | ORIG-1 | Approval | 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 |
---|---|---|---|---|---|
03/10/2019 | SUPPL-2 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
ASPIRIN AND DIPYRIDAMOLE
CAPSULE, EXTENDED RELEASE;ORAL; 25MG;200MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ASPIRIN AND DIPYRIDAMOLE | ASPIRIN; DIPYRIDAMOLE | 25MG;200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206392 | AMNEAL PHARMS |
ASPIRIN AND DIPYRIDAMOLE | ASPIRIN; DIPYRIDAMOLE | 25MG;200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078804 | BARR |
ASPIRIN AND DIPYRIDAMOLE | ASPIRIN; DIPYRIDAMOLE | 25MG;200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209048 | DR REDDYS |
ASPIRIN AND DIPYRIDAMOLE | ASPIRIN; DIPYRIDAMOLE | 25MG;200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207944 | ENDO OPERATIONS |
ASPIRIN AND DIPYRIDAMOLE | ASPIRIN; DIPYRIDAMOLE | 25MG;200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210318 | GLENMARK SPECLT |
ASPIRIN AND DIPYRIDAMOLE | ASPIRIN; DIPYRIDAMOLE | 25MG;200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209929 | MICRO LABS |
ASPIRIN AND DIPYRIDAMOLE | ASPIRIN; DIPYRIDAMOLE | 25MG;200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206739 | SANDOZ |
ASPIRIN AND DIPYRIDAMOLE | ASPIRIN; DIPYRIDAMOLE | 25MG;200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206753 | ZYDUS PHARMS |