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Abbreviated New Drug Application (ANDA): 208295
Company: WATSON LABS TEVA
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
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
10/08/2021 SUPPL-2 Labeling-Package Insert

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 208295 WATSON LABS TEVA
ENTEREG ALVIMOPAN 12MG CAPSULE;ORAL Prescription Yes AB 021775 CUBIST PHARMS
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