Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074623
Company: PHARM ASSOC

Products on ANDA 074623

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074623

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/30/1996	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/24/2020	SUPPL-12	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
03/24/2020	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
03/24/2020	SUPPL-10	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 074623

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