U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 216843
Company: ENDO OPERATIONS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALVIMOPAN ALVIMOPAN 12MG CAPSULE;ORAL Prescription AB No No
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.

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 216843 ENDO OPERATIONS
ALVIMOPAN ALVIMOPAN 12MG CAPSULE;ORAL Prescription No AB 217753 HIKMA
ALVIMOPAN ALVIMOPAN 12MG CAPSULE;ORAL Prescription No AB 208295 WATSON LABS TEVA
Back to Top