Viewing data from:

CEFIXIME

ANDA

CEFIXIME | A218691 | FDC LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: SUPRAX(TE code: AB)

API Supply Chain10 active DMFs5 inactive

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

LUPIN LTDCEFIXIME USP

DMF 159962002

NECTAR LIFESCIENCES LTDCEFIXIME USP

DMF 193072006

ORCHID PHARMA LTDCEFIXIME (PROCESS 2)

DMF 199602006

PURE AND CURE HEALTHCARE PRIVATE LTDCEFIXIME

DMF 234742010

UNIMARK REMEDIES LTDCEFIXIME USP

DMF 260472012

APITORIA PHARMA PRIVATE LTDCEFIXIME USP (NON-STERILE DRUG SUBSTANCE)

DMF 263692012

COVALENT LABORATORIES PRIVATE LTDCEFIXIME USP

DMF 271212013

SANDOZ GMBHCEFIXIME

DMF 275272013

QILU ANTIBIOTICS PHARMACEUTICAL CO LTDCEFIXIME

DMF 366942022

ZHEJIANG APELOA TOSPO PHARMACEUTICAL CO LTDCEFIXIME

DMF 416512025

ASTELLAS PHARMA INCInactiveCEFIXIME

DMF 94781991

LEDERLE LABORATORIESInactiveCEFIXIME

DMF 136871998

SANDOZ PRIVATE LTDInactiveCEFIXIME

DMF 163132002

CSPC ZHONGNUO PHARMACEUTICAL SHIJIAZHUANG CO LTDInactiveCEFIXIME NON-STERILE

DMF 253902011

KYONGBO PHARMACEUTICAL CO LTDInactiveCEFIXIME BULK

DMF 270332013

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

Products (2)

Sort:

#001 — 100MG/5ML

0 patents0 exclusivities▴

FOR SUSPENSION;ORAL | Approved: May 14, 2026

No patent or exclusivity listings for this strength.

#002 — 200MG/5ML

0 patents0 exclusivities▾

FOR SUSPENSION;ORAL | Approved: May 14, 2026

Change History (2)

Recent changes detected for this application.

ADDED7/1/2026

FDC Ltd received FDA approval for Cefixime (cefixime) under application A218691.

New: New record

ADDED7/1/2026

FDC LTD received FDA approval for CEFIXIME (cefixime) under application A218691, supplement 002.

New: New record