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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 017657

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NDA 017657 describes CEPHULAC, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. Additional details are available on the CEPHULAC profile page.

The generic ingredient in CEPHULAC is lactulose. There are twenty drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the lactulose profile page.

Summary for 017657

Tradename:	CEPHULAC
Applicant:	Sanofi Aventis Us
Ingredient:	lactulose
Patents:	0

Medical Subject Heading (MeSH) Categories for 017657

Gastrointestinal Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL, RECTAL			Strength	10GM/15ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Expired US Patents for NDA 017657

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	CEPHULAC	lactulose	SOLUTION;ORAL, RECTAL	017657-001	Approved Prior to Jan 1, 1982	⤷ Get Started Free	⤷ Get Started Free
Sanofi Aventis Us	CEPHULAC	lactulose	SOLUTION;ORAL, RECTAL	017657-001	Approved Prior to Jan 1, 1982	⤷ Get Started Free	⤷ Get Started Free
Sanofi Aventis Us	CEPHULAC	lactulose	SOLUTION;ORAL, RECTAL	017657-001	Approved Prior to Jan 1, 1982	⤷ Get Started Free	⤷ Get Started Free
Sanofi Aventis Us	CEPHULAC	lactulose	SOLUTION;ORAL, RECTAL	017657-001	Approved Prior to Jan 1, 1982	⤷ Get Started Free	⤷ Get Started Free
Sanofi Aventis Us	CEPHULAC	lactulose	SOLUTION;ORAL, RECTAL	017657-001	Approved Prior to Jan 1, 1982	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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