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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209517
Company: CHARTWELL RX

Products on ANDA 209517

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LACTULOSE	LACTULOSE	10GM/15ML	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209517

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/23/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 209517

LACTULOSE

SOLUTION;ORAL; 10GM/15ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LACTULOSE	LACTULOSE	10GM/15ML	SOLUTION;ORAL	Prescription	No	AA	207786	APOZEAL PHARMS
LACTULOSE	LACTULOSE	10GM/15ML	SOLUTION;ORAL	Prescription	No	AA	074602	AUROBINDO PHARMA LTD
LACTULOSE	LACTULOSE	10GM/15ML	SOLUTION;ORAL	Prescription	No	AA	209517	CHARTWELL RX
LACTULOSE	LACTULOSE	10GM/15ML	SOLUTION;ORAL	Prescription	No	AA	090503	FRESENIUS KABI
LACTULOSE	LACTULOSE	10GM/15ML	SOLUTION;ORAL	Prescription	No	AA	075993	LANNETT CO INC
LACTULOSE	LACTULOSE	10GM/15ML	SOLUTION;ORAL	Prescription	No	AA	074623	PHARM ASSOC
LACTULOSE	LACTULOSE	10GM/15ML	SOLUTION;ORAL	Prescription	No	AA	075911	PHARMOBEDIENT
LACTULOSE	LACTULOSE	10GM/15ML	SOLUTION;ORAL	Prescription	No	AA	218858	TARO

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