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): 216843
Company: PAR PHARM

REMS

Products on ANDA 216843

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALVIMOPAN	ALVIMOPAN	12MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216843

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/24/2023	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
06/12/2023	SUPPL-1	REMS - MODIFIED - D-N-A		Label is not available on this site.

Therapeutic Equivalents for ANDA 216843

ALVIMOPAN

CAPSULE;ORAL; 12MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALVIMOPAN	ALVIMOPAN	12MG	CAPSULE;ORAL	Prescription	No	AB	217753	HIKMA
ALVIMOPAN	ALVIMOPAN	12MG	CAPSULE;ORAL	Prescription	No	AB	216843	PAR PHARM
ALVIMOPAN	ALVIMOPAN	12MG	CAPSULE;ORAL	Prescription	No	AB	208295	WATSON LABS TEVA

Top