Details for New Drug Application (NDA): 212239
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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 212239
Tradename: | ITRACONAZOLE |
Applicant: | Annora Pharma |
Ingredient: | itraconazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 212239
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ITRACONAZOLE | itraconazole | SOLUTION;ORAL | 212239 | ANDA | Camber Pharmaceuticals, Inc. | 31722-006 | 31722-006-31 | 1 BOTTLE, GLASS in 1 CARTON (31722-006-31) / 150 mL in 1 BOTTLE, GLASS |
ITRACONAZOLE | itraconazole | SOLUTION;ORAL | 212239 | ANDA | Natco Pharma USA LLC | 69339-159 | 69339-159-17 | 40 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (69339-159-17) / 10 mL in 1 CUP, UNIT-DOSE (69339-159-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 10MG/ML | ||||
Approval Date: | Sep 1, 2020 | TE: | AA | RLD: | No |
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