Details for New Drug Application (NDA): 214770
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NDA 214770 describes NOXAFIL POWDERMIX KIT, which is a drug marketed by Msd Merck Co and is included in one NDA. It is available from one supplier. Additional details are available on the NOXAFIL POWDERMIX KIT profile page.
The generic ingredient in NOXAFIL POWDERMIX KIT 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.
The generic ingredient in NOXAFIL POWDERMIX KIT 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 214770
| Tradename: | NOXAFIL POWDERMIX KIT |
| Applicant: | Msd Merck Co |
| Ingredient: | posaconazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 214770
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NOXAFIL POWDERMIX KIT | posaconazole | FOR SUSPENSION, DELAYED RELEASE;ORAL | 214770 | NDA | Merck Sharp & Dohme LLC | 0085-2224 | 0085-2224-02 | 8 PACKET in 1 CARTON (0085-2224-02) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0085-2224-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION, DELAYED RELEASE;ORAL | Strength | 300MG | ||||
| Approval Date: | May 31, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 31, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
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