Details for New Drug Application (NDA): 209983
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The generic ingredient in POSACONAZOLE is posaconazole. There are twenty-one drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the posaconazole profile page.
Summary for 209983
Tradename: | POSACONAZOLE |
Applicant: | Fresenius Kabi Usa |
Ingredient: | posaconazole |
Patents: | 0 |
Suppliers and Packaging for NDA: 209983
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
POSACONAZOLE | posaconazole | SOLUTION;INTRAVENOUS | 209983 | ANDA | Fresensius Kabi USA, LLC | 63323-685 | 63323-685-17 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-685-17) / 16.7 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 300MG/16.7ML (18MG/ML) | ||||
Approval Date: | Dec 26, 2023 | TE: | AP | RLD: | No |
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