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Details for New Drug Application (NDA): 022003
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The generic ingredient in NOXAFIL is posaconazole. There are twenty-one drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the posaconazole profile page.
Summary for 022003
Tradename: | NOXAFIL |
Applicant: | Schering |
Ingredient: | posaconazole |
Patents: | 1 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 022003
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NOXAFIL | posaconazole | SUSPENSION;ORAL | 022003 | NDA | Merck Sharp & Dohme Corp. | 0085-1328 | 0085-1328-01 | 1 BOTTLE, GLASS in 1 CARTON (0085-1328-01) > 105 mL in 1 BOTTLE, GLASS |
Paragraph IV (Patent) Challenges for 022003
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
NOXAFIL | SUSPENSION;ORAL | posaconazole | 022003 | 2011-02-28 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 40MG/ML | ||||
Approval Date: | Sep 15, 2006 | TE: | RLD: | Yes | |||||
Patent: | Start Trial | Patent Expiration: | Apr 1, 2022 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 022003
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Schering | NOXAFIL | posaconazole | SUSPENSION;ORAL | 022003-001 | Sep 15, 2006 | Start Trial | Start Trial |
Schering | NOXAFIL | posaconazole | SUSPENSION;ORAL | 022003-001 | Sep 15, 2006 | Start Trial | Start Trial |
Schering | NOXAFIL | posaconazole | SUSPENSION;ORAL | 022003-001 | Sep 15, 2006 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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