Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074712
Company: CUMBERLAND PHARMS

Products on ANDA 074712

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074712

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/10/1997	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/97/074712Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/14/2026	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
03/14/2001	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.

Therapeutic Equivalents for ANDA 074712

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