An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 206392
Company: AMNEAL PHARMS

Products on ANDA 206392

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 206392

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/08/2016	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
07/29/2025	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
07/29/2025	SUPPL-19	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
07/29/2025	SUPPL-12	Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 206392

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 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	207944	PH HEALTH
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

Top