FDA Orange Book · active-ingredient family
Ciprofloxacin hydrochloride
Ciprofloxacin hydrochloride: 5 brands, 28 generics; first approved Oct 22, 1987; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 28 ANDA applications approved.
Brands (NDA)
5
Generics (ANDA)
28
Listed patents
0
Presentations
72
Brand (NDA) products
Originator applications
- LAB SALVATNDA 0219182009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.2% BASE SOLUTION/DROPS OTIC Rx AB - SANDOZNDA 0203691998
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.3% BASE OINTMENT OPHTHALMIC Rx — - SANDOZNDA 0199921990
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.3% BASE SOLUTION/DROPS OPHTHALMIC Rx AT - CIPRORLDBAYER HLTHCARENDA 01953719873 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Rx AB EQ 500MG BASE TABLET ORAL Rx AB EQ 750MG BASE TABLET ORAL Discontinued — - DEPOMED INCNDA 0217442005
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued —
Generic (ANDA) products (28)
Abbreviated applications
- CIPROFLOXACIN HYDROCHLORIDEALEMBIC THERAPANDA 2178872024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.2% BASE SOLUTION/DROPS OTIC Rx AB - CIPROFLOXACIN HYDROCHLORIDEYILINGANDA 20892120182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Rx AB EQ 500MG BASE TABLET ORAL Rx AB - CIPROFLOXACIN HYDROCHLORIDEALTAIRE PHARMS INCANDA 2046132018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.3% BASE SOLUTION/DROPS OPHTHALMIC Rx AT - CIPROFLOXACIN HYDROCHLORIDEPHARMOBEDIENTANDA 0765552008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.3% BASE SOLUTION/DROPS OPHTHALMIC Discontinued — - CIPROFLOXACIN HYDROCHLORIDEFDC LTDANDA 0775682008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.3% BASE SOLUTION/DROPS OPHTHALMIC Rx AT - CIPROFLOXACIN HYDROCHLORIDEAMRING PHARMSANDA 0785982008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.3% BASE SOLUTION/DROPS OPHTHALMIC Discontinued — - CIPROFLOXACIN HYDROCHLORIDEAUROBINDO PHARMAANDA 07785920073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Rx AB EQ 500MG BASE TABLET ORAL Rx AB EQ 750MG BASE TABLET ORAL Rx AB - CIPROFLOXACIN HYDROCHLORIDERISINGANDA 0776892006
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.3% BASE SOLUTION/DROPS OPHTHALMIC Rx AT - CIPROFLOXACIN HYDROCHLORIDEPLIVAANDA 07642620053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Discontinued — EQ 500MG BASE TABLET ORAL Discontinued — EQ 750MG BASE TABLET ORAL Discontinued — - CIPROFLOXACIN HYDROCHLORIDEWATSON LABS INCANDA 0766732005
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.3% BASE SOLUTION/DROPS OPHTHALMIC Rx AT - CIPROFLOXACIN HYDROCHLORIDECHARTWELLANDA 07689620043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Rx AB EQ 500MG BASE TABLET ORAL Rx AB EQ 750MG BASE TABLET ORAL Rx AB - CIPROFLOXACIN HYDROCHLORIDETAROANDA 07691220043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Discontinued — EQ 500MG BASE TABLET ORAL Discontinued — EQ 750MG BASE TABLET ORAL Discontinued — - CIPROFLOXACIN HYDROCHLORIDEUNIQUEANDA 07663920043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Rx AB EQ 500MG BASE TABLET ORAL Rx AB EQ 750MG BASE TABLET ORAL Rx AB - CIPROFLOXACIN HYDROCHLORIDERUBICON RESEARCHANDA 0759282004
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.3% BASE SOLUTION/DROPS OPHTHALMIC Rx AT - CIPROFLOXACIN HYDROCHLORIDETHE J MOLNERANDA 0767542004
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.3% BASE SOLUTION/DROPS OPHTHALMIC Discontinued — - CIPROFLOXACIN HYDROCHLORIDEAIPING PHARM INCANDA 07659320043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Rx AB EQ 500MG BASE TABLET ORAL Rx AB EQ 750MG BASE TABLET ORAL Rx AB - CIPROFLOXACIN HYDROCHLORIDEAMNEALANDA 07593920043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Discontinued — EQ 500MG BASE TABLET ORAL Discontinued — EQ 750MG BASE TABLET ORAL Discontinued — - CIPROFLOXACIN HYDROCHLORIDEBARRANDA 07412420043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Discontinued — EQ 500MG BASE TABLET ORAL Discontinued — EQ 750MG BASE TABLET ORAL Discontinued — - CIPROFLOXACIN HYDROCHLORIDECARLSBADANDA 07612620043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Rx AB EQ 500MG BASE TABLET ORAL Rx AB EQ 750MG BASE TABLET ORAL Rx AB - CIPROFLOXACIN HYDROCHLORIDEDR REDDYS LABS LTDANDA 07559320043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 750MG BASE TABLET ORAL Rx AB EQ 250MG BASE TABLET ORAL Rx AB EQ 500MG BASE TABLET ORAL Rx AB - CIPROFLOXACIN HYDROCHLORIDEHIKMAANDA 07655820043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Discontinued — EQ 500MG BASE TABLET ORAL Discontinued — EQ 750MG BASE TABLET ORAL Discontinued — - CIPROFLOXACIN HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 07608920043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Rx AB EQ 500MG BASE TABLET ORAL Rx AB EQ 750MG BASE TABLET ORAL Rx AB - CIPROFLOXACIN HYDROCHLORIDENATCOANDA 07568520043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 750MG BASE TABLET ORAL Discontinued — EQ 250MG BASE TABLET ORAL Discontinued — EQ 500MG BASE TABLET ORAL Discontinued — - CIPROFLOXACIN HYDROCHLORIDENOSTRUM LABSANDA 07613820043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Discontinued — EQ 500MG BASE TABLET ORAL Discontinued — EQ 750MG BASE TABLET ORAL Discontinued — - CIPROFLOXACIN HYDROCHLORIDERISINGANDA 07581720043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Discontinued — EQ 500MG BASE TABLET ORAL Rx AB EQ 750MG BASE TABLET ORAL Discontinued — - CIPROFLOXACIN HYDROCHLORIDESUN PHARM INDS LTDANDA 07574720043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Discontinued — EQ 500MG BASE TABLET ORAL Discontinued — EQ 750MG BASE TABLET ORAL Discontinued — - CIPROFLOXACIN HYDROCHLORIDETEVAANDA 07613620043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Discontinued — EQ 500MG BASE TABLET ORAL Discontinued — EQ 750MG BASE TABLET ORAL Discontinued — - CIPROFLOXACIN HYDROCHLORIDEWATSON LABSANDA 07679420043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Rx AB EQ 500MG BASE TABLET ORAL Rx AB EQ 750MG BASE TABLET ORAL Rx AB
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
39 yr 5 mo ago
Most recent approval
1 yr 10 mo ago
Approvals span 1987–2024 across 33 FDA applications.
Brand (NDA) 515%
Generic (ANDA) 2885%
Ciprofloxacin hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
