Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 206938
Company: BELCHER

Products on ANDA 206938

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEFIXIME	CEFIXIME	100MG/5ML	FOR SUSPENSION;ORAL	Prescription	AB	No	No
CEFIXIME	CEFIXIME	200MG/5ML	FOR SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206938

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/06/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 206938

CEFIXIME

FOR SUSPENSION;ORAL; 100MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEFIXIME	CEFIXIME	100MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	211775	ALKEM LABS LTD
CEFIXIME	CEFIXIME	100MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	204835	AUROBINDO PHARMA LTD
CEFIXIME	CEFIXIME	100MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	206938	BELCHER

FOR SUSPENSION;ORAL; 200MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEFIXIME	CEFIXIME	200MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	211775	ALKEM LABS LTD
CEFIXIME	CEFIXIME	200MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	204835	AUROBINDO PHARMA LTD
CEFIXIME	CEFIXIME	200MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	206938	BELCHER
SUPRAX	CEFIXIME	200MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065355	LUPIN PHARMS