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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076593
Company: AIPING PHARM INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CIPROFLOXACIN CIPROFLOXACIN 100MG Tablet; Oral None (Tentative Approval) None No No
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription AB No No
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription AB No No
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET;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
03/16/2004 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76593ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/31/2017 SUPPL-4 Labeling-Package Insert

Label is not available on this site.
10/31/2017 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

CIPROFLOXACIN

There are no Therapeutic Equivalents.

CIPROFLOXACIN HYDROCHLORIDE

TABLET;ORAL; EQ 250MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CIPRO CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription Yes AB 019537 BAYER HLTHCARE
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 076593 AIPING PHARM INC
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 077859 AUROBINDO PHARMA
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 076126 CARLSBAD
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 076896 CHARTWELL
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 075593 DR REDDYS LABS LTD
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 076558 HIKMA
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 076089 IVAX SUB TEVA PHARMS
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 076639 UNIQUE
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 076794 WATSON LABS
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 208921 YILING

TABLET;ORAL; EQ 500MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CIPRO CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription Yes AB 019537 BAYER HLTHCARE
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 076593 AIPING PHARM INC
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 077859 AUROBINDO PHARMA
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 076126 CARLSBAD
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 076896 CHARTWELL
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 075593 DR REDDYS LABS LTD
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 076558 HIKMA
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 076089 IVAX SUB TEVA PHARMS
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 075817 RISING
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 076639 UNIQUE
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 076794 WATSON LABS
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Prescription No AB 208921 YILING

TABLET;ORAL; EQ 750MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET;ORAL Prescription No AB 076593 AIPING PHARM INC
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET;ORAL Prescription No AB 077859 AUROBINDO PHARMA
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET;ORAL Prescription No AB 076126 CARLSBAD
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET;ORAL Prescription No AB 076896 CHARTWELL
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET;ORAL Prescription No AB 075593 DR REDDYS LABS LTD
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET;ORAL Prescription No AB 076558 HIKMA
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET;ORAL Prescription No AB 076089 IVAX SUB TEVA PHARMS
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET;ORAL Prescription No AB 076639 UNIQUE
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET;ORAL Prescription No AB 076794 WATSON LABS
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