Details for New Drug Application (NDA): 205991
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The generic ingredient in ITRACONAZOLE is itraconazole. There are fifteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the itraconazole profile page.
Summary for 205991
Tradename: | ITRACONAZOLE |
Applicant: | Accord Hlthcare |
Ingredient: | itraconazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 205991
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ITRACONAZOLE | itraconazole | CAPSULE;ORAL | 205991 | ANDA | Accord Healthcare Inc. | 16729-271 | 16729-271-10 | 30 CAPSULE in 1 BOTTLE (16729-271-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | May 26, 2016 | TE: | AB | RLD: | No |
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