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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206753
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 210318 GLENMARK PHARMS SA
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 207944 PAR PHARM INC
ASPIRIN AND DIPYRIDAMOLE ASPIRIN; DIPYRIDAMOLE 25MG;200MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206739 SANDOZ INC
ASPIRIN AND DIPYRIDAMOLE ASPIRIN; DIPYRIDAMOLE 25MG;200MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206753 ZYDUS PHARMS
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