Details for New Drug Application (NDA): 022259

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NDA 022259 describes TOLAK, which is a drug marketed by Hill Dermaceuticals and is included in one NDA. It is available from one supplier. Additional details are available on the TOLAK profile page.

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

Summary for 022259

Tradename:	TOLAK
Applicant:	Hill Dermaceuticals
Ingredient:	fluorouracil
Patents:	0

Pharmacology for NDA: 022259

Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Medical Subject Heading (MeSH) Categories for 022259

Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents

Suppliers and Packaging for NDA: 022259

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOLAK	fluorouracil	CREAM;TOPICAL	022259	NDA	HILL DERMACEUTICALS, INC.	28105-421	28105-421-40	1 TUBE in 1 CARTON (28105-421-40) / 40 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	4%
Approval Date:	Sep 18, 2015	TE:		RLD:	Yes

Expired US Patents for NDA 022259

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hill Dermaceuticals	TOLAK	fluorouracil	CREAM;TOPICAL	022259-001	Sep 18, 2015	7,169,401	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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