Details for New Drug Application (NDA): 212411
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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 212411
Tradename: | POSACONAZOLE |
Applicant: | Sinotherapeutics Inc |
Ingredient: | posaconazole |
Patents: | 0 |
Suppliers and Packaging for NDA: 212411
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
POSACONAZOLE | posaconazole | TABLET, DELAYED RELEASE;ORAL | 212411 | ANDA | Lannett Company Inc. | 0527-2133 | 0527-2133-30 | 24 TABLET, DELAYED RELEASE in 1 CARTON (0527-2133-30) |
POSACONAZOLE | posaconazole | TABLET, DELAYED RELEASE;ORAL | 212411 | ANDA | Lannett Company Inc. | 0527-2133 | 0527-2133-35 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (0527-2133-35) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 100MG | ||||
Approval Date: | Aug 21, 2019 | TE: | AB | RLD: | No |
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