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Details for New Drug Application (NDA): 022404

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NDA 022404 describes ORAVIG, which is a drug marketed by Midatech Pharma Us and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. 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 NDA: 022404

Tradename:
ORAVIG
Applicant:
Midatech Pharma Us
Ingredient:
miconazole
Patents:3
Formulation / Manufacturing:see details

Pharmacology for NDA: 022404

Ingredient-typeAzoles

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 Midatech Pharma US, Inc. 89141-250 89141-250-02 1 BOTTLE in 1 CARTON (89141-250-02) > 2 TABLET in 1 BOTTLE
ORAVIG
miconazole
TABLET;BUCCAL 022404 NDA Midatech Pharma US, Inc. 89141-250 89141-250-14 1 BOTTLE in 1 CARTON (89141-250-14) > 14 TABLET in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;BUCCALStrength50MG
Approval Date:Apr 16, 2010TE:RLD:Yes
Patent:8,518,442Patent Expiration:Sep 11, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:6,916,485Patent Expiration:Sep 11, 2022Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF OROPHARYNGEAL CANDIDIASIS
Patent:7,651,698Patent Expiration:Sep 11, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF OROPHARYNGEAL CANDIDIASIS


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