Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076754
Company: TELIGENT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 0.3% BASE SOLUTION/DROPS;OPHTHALMIC Prescription AT 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
06/09/2004 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76754ltr.pdf

CIPROFLOXACIN HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC; EQ 0.3% BASE
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CILOXAN CIPROFLOXACIN HYDROCHLORIDE EQ 0.3% BASE SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 019992 NOVARTIS
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 0.3% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 076555 AKORN
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 0.3% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 204613 ALTAIRE PHARMS INC
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 0.3% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 077568 FDC LTD
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 0.3% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 077689 RISING
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 0.3% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 076754 TELIGENT
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 0.3% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 076673 WATSON LABS INC

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