Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217914
Company: PAI HOLDINGS

Products on ANDA 217914

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LACTULOSE	LACTULOSE	10GM/PACKET	FOR SOLUTION;ORAL	Prescription	AA	No	No
LACTULOSE	LACTULOSE	20GM/PACKET	FOR SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217914

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/14/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217914

LACTULOSE

FOR SOLUTION;ORAL; 10GM/PACKET
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LACTULOSE	LACTULOSE	10GM/PACKET	FOR SOLUTION;ORAL	Prescription	No	AA	074712	CUMBERLAND PHARMS
LACTULOSE	LACTULOSE	10GM/PACKET	FOR SOLUTION;ORAL	Prescription	No	AA	217914	PAI HOLDINGS

FOR SOLUTION;ORAL; 20GM/PACKET
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LACTULOSE	LACTULOSE	20GM/PACKET	FOR SOLUTION;ORAL	Prescription	No	AA	074712	CUMBERLAND PHARMS
LACTULOSE	LACTULOSE	20GM/PACKET	FOR SOLUTION;ORAL	Prescription	No	AA	217914	PAI HOLDINGS