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Itraconazole - 0378-5100-93 - (itraconazole)

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Drug Information of Itraconazole

Product NDC: 0378-5100
Proprietary Name: Itraconazole
Non Proprietary Name: itraconazole
Active Ingredient(s): 100    mg/1 & nbsp;   itraconazole
Administration Route(s): ORAL
Dosage Form(s): CAPSULE
Coding System: National Drug Codes(NDC)

Labeler Information of Itraconazole

Product NDC: 0378-5100
Labeler Name: Mylan Pharmaceuticals Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA200463
Marketing Category: ANDA
Start Marketing Date: 20120720

Package Information of Itraconazole

Package NDC: 0378-5100-93
Package Description: 30 CAPSULE in 1 BOTTLE, PLASTIC (0378-5100-93)

NDC Information of Itraconazole

NDC Code 0378-5100-93
Proprietary Name Itraconazole
Package Description 30 CAPSULE in 1 BOTTLE, PLASTIC (0378-5100-93)
Product NDC 0378-5100
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name itraconazole
Dosage Form Name CAPSULE
Route Name ORAL
Start Marketing Date 20120720
Marketing Category Name ANDA
Labeler Name Mylan Pharmaceuticals Inc.
Substance Name ITRACONAZOLE
Strength Number 100
Strength Unit mg/1
Pharmaceutical Classes Azole Antifungal [EPC],Azoles [Chemical/Ingredient]

Complete Information of Itraconazole


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