Details for New Drug Application (NDA): 208768
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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 208768
Tradename: | POSACONAZOLE |
Applicant: | Endo Operations |
Ingredient: | posaconazole |
Patents: | 0 |
Suppliers and Packaging for NDA: 208768
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
POSACONAZOLE | posaconazole | SOLUTION;INTRAVENOUS | 208768 | ANDA | ENDO USA, Inc. | 42023-195 | 42023-195-01 | 1 VIAL, GLASS in 1 CARTON (42023-195-01) / 16.7 mL in 1 VIAL, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 300MG/16.7ML (18MG/ML) | ||||
Approval Date: | May 25, 2022 | TE: | AP | RLD: | No |
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