Details for New Drug Application (NDA): 020310

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NDA 020310 describes NIZORAL ANTI-DANDRUFF, which is a drug marketed by Kramer and is included in one NDA. It is available from one supplier. Additional details are available on the NIZORAL ANTI-DANDRUFF profile page.

The generic ingredient in NIZORAL ANTI-DANDRUFF is ketoconazole. There are fifteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.

Summary for 020310

Tradename:	NIZORAL ANTI-DANDRUFF
Applicant:	Kramer
Ingredient:	ketoconazole
Patents:	0

Pharmacology for NDA: 020310

Mechanism of Action	Cytochrome P450 3A4 Inhibitors Cytochrome P450 3A5 Inhibitors P-Glycoprotein Inhibitors

Medical Subject Heading (MeSH) Categories for 020310

14-alpha Demethylase Inhibitors
Antifungal Agents
Cytochrome P-450 CYP3A Inhibitors

Suppliers and Packaging for NDA: 020310

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NIZORAL ANTI-DANDRUFF	ketoconazole	SHAMPOO;TOPICAL	020310	NDA	Kramer Laboratories	55505-196	55505-196-33	1 BOTTLE in 1 CARTON (55505-196-33) / 125 mL in 1 BOTTLE
NIZORAL ANTI-DANDRUFF	ketoconazole	SHAMPOO;TOPICAL	020310	NDA	Kramer Laboratories	55505-196	55505-196-40	1 BOTTLE in 1 CARTON (55505-196-40) / 200 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	SHAMPOO;TOPICAL			Strength	1%
Approval Date:	Oct 10, 1997	TE:		RLD:	Yes

Expired US Patents for NDA 020310

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kramer	NIZORAL ANTI-DANDRUFF	ketoconazole	SHAMPOO;TOPICAL	020310-001	Oct 10, 1997	4,335,125	⤷ Get Started Free
Kramer	NIZORAL ANTI-DANDRUFF	ketoconazole	SHAMPOO;TOPICAL	020310-001	Oct 10, 1997	4,942,162	⤷ Get Started Free
Kramer	NIZORAL ANTI-DANDRUFF	ketoconazole	SHAMPOO;TOPICAL	020310-001	Oct 10, 1997	5,456,851	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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