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Drugs@FDA: FDA-Approved Drugs

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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.cfm 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
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
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
SUPRAX	CEFIXIME	400MG	CAPSULE;ORAL	Prescription	Yes	AB	203195	LUPIN LTD

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