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 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	55505-192	55505-192-33	1 BOTTLE in 1 CARTON (55505-192-33) / 125 mL in 1 BOTTLE
NIZORAL ANTI-DANDRUFF	ketoconazole	SHAMPOO;TOPICAL	020310	NDA	Kramer Laboratories	55505-192	55505-192-40	1 BOTTLE in 1 CARTON (55505-192-40) / 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	⤷ Get Started Free	⤷ Get Started Free
Kramer	NIZORAL ANTI-DANDRUFF	ketoconazole	SHAMPOO;TOPICAL	020310-001	Oct 10, 1997	⤷ Get Started Free	⤷ Get Started Free
Kramer	NIZORAL ANTI-DANDRUFF	ketoconazole	SHAMPOO;TOPICAL	020310-001	Oct 10, 1997	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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