Last Updated: September 24, 2026

Details for New Drug Application (NDA): 022404

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NDA 022404 describes ORAVIG, which is a drug marketed by Galt Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the ORAVIG profile page.

The generic ingredient in ORAVIG is miconazole. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the miconazole profile page.

Summary for 022404

Tradename:	ORAVIG
Applicant:	Galt Pharms
Ingredient:	miconazole
Patents:	0

Pharmacology for NDA: 022404

Medical Subject Heading (MeSH) Categories for 022404

14-alpha Demethylase Inhibitors
Antifungal Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors

Suppliers and Packaging for NDA: 022404

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ORAVIG	miconazole	TABLET;BUCCAL	022404	NDA	Galt Pharmaceuticals, LLC	61825-303	61825-303-14	14 TABLET in 1 BOTTLE (61825-303-14)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;BUCCAL			Strength	50MG
Approval Date:	Apr 16, 2010	TE:		RLD:	Yes

Expired US Patents for NDA 022404

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galt Pharms	ORAVIG	miconazole	TABLET;BUCCAL	022404-001	Apr 16, 2010	6,916,485	⤷ Start Trial
Galt Pharms	ORAVIG	miconazole	TABLET;BUCCAL	022404-001	Apr 16, 2010	8,518,442	⤷ Start Trial
Galt Pharms	ORAVIG	miconazole	TABLET;BUCCAL	022404-001	Apr 16, 2010	7,651,698	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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