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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210318
Company: GLENMARK PHARMS SA

Products on ANDA 210318

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210318

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/24/2019	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
11/16/2021	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
04/14/2021	SUPPL-1	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 210318

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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