Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075911
Company: XTTRIUM LABS INC

Products on ANDA 075911

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 075911

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/21/2002	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75911APD.pdf

Therapeutic Equivalents for ANDA 075911

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	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	XTTRIUM LABS INC