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Details for New Drug Application (NDA): 022003
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NDA 022003 describes NOXAFIL, which is a drug marketed by Merck Sharp Dohme and Schering and is included in three NDAs. It is available from two suppliers. There are seven patents protecting this drug and three Paragraph IV challenges. Additional details are available on the NOXAFIL profile page.
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.
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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