Details for New Drug Application (NDA): 212226
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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 212226
Tradename: | POSACONAZOLE |
Applicant: | Specgx Llc |
Ingredient: | posaconazole |
Patents: | 0 |
Suppliers and Packaging for NDA: 212226
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
POSACONAZOLE | posaconazole | TABLET, DELAYED RELEASE;ORAL | 212226 | ANDA | SpecGx LLC | 0406-7711 | 0406-7711-60 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (0406-7711-60) |
POSACONAZOLE | posaconazole | TABLET, DELAYED RELEASE;ORAL | 212226 | ANDA | Golden State Medical Supply, Inc. | 51407-676 | 51407-676-60 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (51407-676-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 100MG | ||||
Approval Date: | May 10, 2022 | TE: | AB | RLD: | No |
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