gynazole 1 - 64011-246-01 - (Butoconazole Nitrate)

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Drug Information of gynazole 1

Product NDC: 64011-246
Proprietary Name: gynazole 1
Non Proprietary Name: Butoconazole Nitrate
Active Ingredient(s): 100    mg/5g & nbsp;   Butoconazole Nitrate
Administration Route(s): VAGINAL
Dosage Form(s): CREAM
Coding System: National Drug Codes(NDC)

Labeler Information of gynazole 1

Product NDC: 64011-246
Labeler Name: Ther-Rx Corporation
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA200923
Marketing Category: ANDA
Start Marketing Date: 20121227

Package Information of gynazole 1

Package NDC: 64011-246-01
Package Description: 1 TUBE in 1 CARTON (64011-246-01) > 5.8 g in 1 TUBE

NDC Information of gynazole 1

NDC Code 64011-246-01
Proprietary Name gynazole 1
Package Description 1 TUBE in 1 CARTON (64011-246-01) > 5.8 g in 1 TUBE
Product NDC 64011-246
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Butoconazole Nitrate
Dosage Form Name CREAM
Route Name VAGINAL
Start Marketing Date 20121227
Marketing Category Name ANDA
Labeler Name Ther-Rx Corporation
Substance Name BUTOCONAZOLE NITRATE
Strength Number 100
Strength Unit mg/5g
Pharmaceutical Classes Azole Antifungal [EPC],Azoles [Chemical/Ingredient]

Complete Information of gynazole 1


General Information