An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 203195
Company: LUPIN LTD

Summary Review

Products on NDA 203195

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SUPRAX	CEFIXIME	400MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203195

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/01/2012	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203195s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203195s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203195_suprax_toc.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203195Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/22/2025	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/203195s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/203195Orig1s013ltr.pdf
06/29/2018	SUPPL-9		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203195s009lbl.pdf
03/30/2018	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202091S007_203195_S008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202091Orig1s007,203195Orig1s008ltr.pdf
03/16/2017	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202091s005,203195s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203195Orig1s006,202091Orig1s005ltr.pdf
01/07/2016	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202091s004,203195s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202091Orig1s004,203195Orig1s005ltr.pdf
11/22/2013	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/18/2013	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
03/26/2013	SUPPL-1	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203195s001lbl.pdf

Labels for NDA 203195

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/22/2025	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/203195s013lbl.pdf
06/29/2018	SUPPL-9	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203195s009lbl.pdf
03/30/2018	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202091S007_203195_S008lbl.pdf
03/16/2017	SUPPL-6	Labeling-Package Insert	Label (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202091s005,203195s006lbl.pdf
01/07/2016	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202091s004,203195s005lbl.pdf
03/26/2013	SUPPL-1	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203195s001lbl.pdf
06/01/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203195s000lbl.pdf

Therapeutic Equivalents for NDA 203195

SUPRAX

CAPSULE;ORAL; 400MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEFIXIME	CEFIXIME	400MG	CAPSULE;ORAL	Prescription	No	AB	210574	ALKEM LABS LTD
CEFIXIME	CEFIXIME	400MG	CAPSULE;ORAL	Prescription	No	AB	217607	AUROBINDO PHARMA LTD
SUPRAX	CEFIXIME	400MG	CAPSULE;ORAL	Prescription	Yes	AB	203195	LUPIN LTD

Top