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CIPROFLOXACIN HYDROCHLORIDE

ANDA

CIPROFLOXACIN HYDROCHLORIDE | A217887 | ALEMBIC THERAPEUTICS LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: CETRAXAL(TE code: AB)

API Supply Chain8 active DMFs12 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

BAYER AGCIPROFLOXACIN HYDROCHLORIDE

DMF 81341989

QUIMICA SINTETICA SACIPROFLOXACIN HYDROCHLORIDE

DMF 119661996

NEULAND LABORATORIES LTDCIPROFLOXACIN HYDROCHLORIDE USP

DMF 132501998

ZHEJIANG HUAYI PHARMACEUTICAL CO LTDCIPROFLOXACIN HYDROCHLORIDE

DMF 180832004

AARTI DRUGS LTDCIPROFLOXACIN HYDROCHLORIDE

DMF 196112006

THINQ PHARMA-CRO LTDCIPROFLOXACIN HYDROCHLORIDE USP

DMF 306162016

TURTLE PHARMA PRIVATE LTDCIPROFLOXACIN HYDROCHLORIDE USP

DMF 332452018

PHLOW CORPCIPROFLOXACIN HYDROCHLORIDE USP

DMF 372062024

QUIMICA SINTETICA SAInactiveCIPROFLOXACIN HYDROCHLORIDE

DMF 85171990

CIPLA LTDInactiveCIPROFLOXACIN HYDROCHLORIDE USP IN BANGALORE, INDIA

DMF 86271990

UNION QUIMICO FARMACEUTICA SAInactiveCIPROFLOXACIN HYDROCHLORIDE

DMF 116021996

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveCIPROFLOXACIN HYDROCHLORIDE USP

DMF 130721998

CIPLA LTDInactiveCIPROFLOXACIN HYDROCHLORIDE USP

DMF 147092000

MYLAN LABORATORIES LTDInactiveCIPROFLOXACIN HYDROCHLORIDE USP

DMF 165442003

UNIQUE CHEMICALSInactiveCIPROFLOXACIN HYDROCHLORIDE USP

DMF 177862004

APITORIA PHARMA PRIVATE LTDInactiveCIPROFLOXACIN HYDROCHLORIDE USP

DMF 185582005

ZHEJIANG XINHUA PHARMACEUTICAL CO LTDInactiveCIPROFLOXACIN HYDROCHLORIDE

DMF 198762006

ZHEJIANG JINGXIN PHARMACEUTICAL CO LTDInactiveCIPROFLOXACIN HYDROCHLORIDE

DMF 203372007

INDOCO REMEDIES LTDInactiveCIPROFLOXACIN HYDROCHLORIDE USP

DMF 219092008

SMRUTHI ORGANICS LTDInactiveCIPROFLOXACIN HYDROCHLORIDE USP

DMF 246362011

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — EQ 0.2% BASE

0 patents0 exclusivities▴

SOLUTION/DROPS;OTIC | Approved: Nov 5, 2024

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Alembic Therapeutics replaced New Heights Rx as the listed applicant for ciprofloxacin hydrochloride oral solution (NDA 217887).

Old: NEW HEIGHTSRX

New: ALEMBIC THERAP

MODIFIEDApplicant Full Name7/1/2026

Alembic Therapeutics LLC replaced New Heights Rx LLC as the applicant for Ciprofloxacin Hydrochloride (NDA 217887).

Old: NEW HEIGHTSRX LLC

New: ALEMBIC THERAPEUTICS LLC