Details for New Drug Application (NDA): 216488
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The generic ingredient in POSACONAZOLE is posaconazole. There are twenty-one drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the posaconazole profile page.
Summary for 216488
Tradename: | POSACONAZOLE |
Applicant: | I 3 Pharms |
Ingredient: | posaconazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 216488
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
POSACONAZOLE | posaconazole | TABLET, DELAYED RELEASE;ORAL | 216488 | ANDA | Bryant Ranch Prepack | 72162-2243 | 72162-2243-6 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (72162-2243-6) |
POSACONAZOLE | posaconazole | TABLET, DELAYED RELEASE;ORAL | 216488 | ANDA | i3 Pharmaceuticals, LLC | 72319-023 | 72319-023-02 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (72319-023-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 100MG | ||||
Approval Date: | Aug 28, 2023 | TE: | AB | RLD: | No |
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