Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200563
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CIPROFLOXACIN CIPROFLOXACIN 250MG/5ML FOR SUSPENSION;ORAL Prescription AB No No
CIPROFLOXACIN CIPROFLOXACIN 500MG/5ML FOR SUSPENSION;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
03/05/2014 ORIG-1 Approval Not Applicable Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200563Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/14/2015 SUPPL-2 Labeling-Medication Guide, Labeling-Container/Carton Labels

Label is not available on this site.

02/06/2015 SUPPL-1 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

CIPROFLOXACIN

FOR SUSPENSION;ORAL; 250MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CIPRO CIPROFLOXACIN 250MG/5ML FOR SUSPENSION;ORAL Prescription Yes AB 020780 BAYER HLTHCARE
CIPROFLOXACIN CIPROFLOXACIN 250MG/5ML FOR SUSPENSION;ORAL Prescription No AB 200563 LUPIN LTD

FOR SUSPENSION;ORAL; 500MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CIPRO CIPROFLOXACIN 500MG/5ML FOR SUSPENSION;ORAL Prescription Yes AB 020780 BAYER HLTHCARE
CIPROFLOXACIN CIPROFLOXACIN 500MG/5ML FOR SUSPENSION;ORAL Prescription No AB 200563 LUPIN LTD

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