Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076645
Company: BAJAJ

Products on ANDA 076645

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076645

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/28/2003	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
02/20/2024	SUPPL-7	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076645

LACTULOSE

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GENERLAC	LACTULOSE	10GM/15ML	SOLUTION;ORAL, RECTAL	Prescription	No	AA	074603	CHARTWELL RX
LACTULOSE	LACTULOSE	10GM/15ML	SOLUTION;ORAL, RECTAL	Prescription	No	AA	076645	BAJAJ
LACTULOSE	LACTULOSE	10GM/15ML	SOLUTION;ORAL, RECTAL	Prescription	No	AA	090502	FRESENIUS KABI
LACTULOSE	LACTULOSE	10GM/15ML	SOLUTION;ORAL, RECTAL	Prescription	No	AA	203762	SCIEGEN PHARMS