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 two suppliers. 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. Forty-eight 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:	0

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	0002-4463	0002-4463-30	30 TABLET, FILM COATED in 1 BOTTLE (0002-4463-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Nov 21, 2003	TE:	AB1	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Nov 21, 2003	TE:	AB1	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Nov 21, 2003	TE:	AB1	RLD:	Yes

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

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