Details for New Drug Application (NDA): 213454
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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 213454
Tradename: | POSACONAZOLE |
Applicant: | Aet Pharma |
Ingredient: | posaconazole |
Patents: | 0 |
Suppliers and Packaging for NDA: 213454
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
POSACONAZOLE | posaconazole | TABLET, DELAYED RELEASE;ORAL | 213454 | ANDA | Major Pharmaceuticals | 0904-7149 | 0904-7149-04 | 30 BLISTER PACK in 1 CARTON (0904-7149-04) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK |
POSACONAZOLE | posaconazole | TABLET, DELAYED RELEASE;ORAL | 213454 | ANDA | Major Pharmaceuticals | 0904-7149 | 0904-7149-10 | 20 BLISTER PACK in 1 CARTON (0904-7149-10) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 100MG | ||||
Approval Date: | Feb 1, 2021 | TE: | AB | RLD: | No |
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