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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078804
Company: BARR

Products on ANDA 078804

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078804

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/14/2009	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078804s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/05/2022	SUPPL-10	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
02/27/2020	SUPPL-7	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
02/27/2020	SUPPL-6	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
05/02/2018	SUPPL-2	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 078804

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
ASPIRIN AND DIPYRIDAMOLE	ASPIRIN; DIPYRIDAMOLE	25MG;200MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	206753	ZYDUS PHARMS

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