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Last Updated: March 28, 2024

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 are twenty-eight drug master file entries 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 022404
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:RXDosage:TABLET;BUCCALStrength50MG
Approval Date:Apr 16, 2010TE:RLD:Yes

Expired US Patents for NDA 022404

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galt Pharms ORAVIG miconazole TABLET;BUCCAL 022404-001 Apr 16, 2010 ⤷  Try a Trial ⤷  Try a Trial
Galt Pharms ORAVIG miconazole TABLET;BUCCAL 022404-001 Apr 16, 2010 ⤷  Try a Trial ⤷  Try a Trial
Galt Pharms ORAVIG miconazole TABLET;BUCCAL 022404-001 Apr 16, 2010 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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