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): 212600
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PIRFENIDONE PIRFENIDONE 267MG 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
06/13/2022 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212600Orig1s000TAltr.pdf

PIRFENIDONE

CAPSULE;ORAL; 267MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESBRIET PIRFENIDONE 267MG CAPSULE;ORAL Prescription Yes AB 022535 GENENTECH INC
PIRFENIDONE PIRFENIDONE 267MG CAPSULE;ORAL Prescription No AB 212731 ACCORD HLTHCARE
PIRFENIDONE PIRFENIDONE 267MG CAPSULE;ORAL Prescription No AB 212569 AMNEAL
PIRFENIDONE PIRFENIDONE 267MG CAPSULE;ORAL Prescription No AB 212724 LAURUS
PIRFENIDONE PIRFENIDONE 267MG CAPSULE;ORAL Prescription No AB 212600 SANDOZ INC
PIRFENIDONE PIRFENIDONE 267MG CAPSULE;ORAL Prescription No AB 212077 SCIEGEN PHARMS INC
Back to Top