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): 065264
Company: LUPIN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFDINIR CEFDINIR 300MG 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
05/19/2006 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/065264s000LTR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/11/2020 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

02/01/2010 SUPPL-9 Labeling

Label is not available on this site.

06/11/2008 SUPPL-4 Labeling

Label is not available on this site.

12/20/2007 SUPPL-3 Labeling

Label is not available on this site.

09/07/2007 SUPPL-2 Labeling

Label is not available on this site.

CEFDINIR

CAPSULE;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFDINIR CEFDINIR 300MG CAPSULE;ORAL Prescription No AB 210220 ALKEM LABS LTD
CEFDINIR CEFDINIR 300MG CAPSULE;ORAL Prescription No AB 065418 ANDA REPOSITORY
CEFDINIR CEFDINIR 300MG CAPSULE;ORAL Prescription No AB 065434 AUROBINDO PHARMA
CEFDINIR CEFDINIR 300MG CAPSULE;ORAL Prescription No AB 065264 LUPIN
CEFDINIR CEFDINIR 300MG CAPSULE;ORAL Prescription No AB 065330 SANDOZ
CEFDINIR CEFDINIR 300MG CAPSULE;ORAL Prescription No AB 065368 TEVA PHARMS
Back to Top