Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208295
Company: WATSON LABS TEVA

• REMS

Products on ANDA 208295

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208295

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/19/2019	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208295Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/23/2025	SUPPL-5	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/208295Orig1s005ltr.pdf
06/12/2023	SUPPL-4	REMS - MODIFIED - D-N-A		Label is not available on this site.
10/08/2021	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208295

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	PH HEALTH
ALVIMOPAN	ALVIMOPAN	12MG	CAPSULE;ORAL	Prescription	No	AB	208295	WATSON LABS TEVA