Details for New Drug Application (NDA): 021368

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NDA 021368 describes CIALIS, which is a drug marketed by Lilly and is included in one NDA. It is available from nine suppliers. There are four patents protecting this drug and two Paragraph IV challenges. Additional details are available on the CIALIS profile page.

The generic ingredient in CIALIS is tadalafil. There are twenty-five drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the tadalafil profile page.

Summary for 021368

Tradename:	CIALIS
Applicant:	Lilly
Ingredient:	tadalafil
Patents:	4
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021368

Mechanism of Action	Phosphodiesterase 5 Inhibitors

Medical Subject Heading (MeSH) Categories for 021368

Phosphodiesterase 5 Inhibitors
Urological Agents
Vasodilator Agents

Suppliers and Packaging for NDA: 021368

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CIALIS	tadalafil	TABLET;ORAL	021368	NDA	Eli Lilly and Company	0002-4462	0002-4462-30	30 TABLET, FILM COATED in 1 BOTTLE (0002-4462-30)
CIALIS	tadalafil	TABLET;ORAL	021368	NDA	Eli Lilly and Company	0002-4462	0002-4462-34	2 BLISTER PACK in 1 CARTON (0002-4462-34) > 15 TABLET, FILM COATED in 1 BLISTER PACK (0002-4462-79)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Nov 21, 2003	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	Feb 15, 2021
Regulatory Exclusivity Use:	INFORMATION ADDED TO THE PEDIATRIC USE SECTION OF THE LABELING REGARDING A NEW CLINICAL TRIAL IN PATIENTS 7 TO 14 YEARS OF AGE WITH DUCHENNE MUSCULAR DYSTROPHY
Regulatory Exclusivity Expiration:	Aug 15, 2021
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY
Patent:	➤ Sign Up	Patent Expiration:	May 21, 2018	Product Flag?		Substance Flag?		Delist Request?

Expired US Patents for NDA 021368

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-004	Jan 7, 2008	➤ Sign Up	➤ Sign Up
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-001	Nov 21, 2003	➤ Sign Up	➤ Sign Up
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-002	Nov 21, 2003	➤ Sign Up	➤ Sign Up
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-003	Nov 21, 2003	➤ Sign Up	➤ Sign Up
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-002	Nov 21, 2003	➤ Sign Up	➤ Sign Up
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-001	Nov 21, 2003	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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