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Details for New Drug Application (NDA): 021026
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NDA 021026 describes VUSION, which is a drug marketed by Mylan and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the VUSION profile page.
The generic ingredient in VUSION is miconazole nitrate; petrolatum, white; zinc oxide. There are twenty-eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the miconazole nitrate; petrolatum, white; zinc oxide profile page.
The generic ingredient in VUSION is miconazole nitrate; petrolatum, white; zinc oxide. There are twenty-eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the miconazole nitrate; petrolatum, white; zinc oxide profile page.
Summary for 021026
| Tradename: | VUSION |
| Applicant: | Mylan |
| Ingredient: | miconazole nitrate; petrolatum, white; zinc oxide |
| Patents: | 1 |
Generic Entry Opportunity Date for 021026
Generic Entry Date for 021026*:
Constraining patent/regulatory exclusivity:
Dosage:
OINTMENT;TOPICAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 021026
Suppliers and Packaging for NDA: 021026
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VUSION | miconazole nitrate; petrolatum, white; zinc oxide | OINTMENT;TOPICAL | 021026 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 0378-8222 | 0378-8222-50 | 1 TUBE in 1 CARTON (0378-8222-50) > 50 g in 1 TUBE |
| VUSION | miconazole nitrate; petrolatum, white; zinc oxide | OINTMENT;TOPICAL | 021026 | NDA | Mylan Pharmaceuticals Inc. | 0378-9730 | 0378-9730-50 | 1 TUBE in 1 CARTON (0378-9730-50) > 50 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 0.25%;81.35%;15% | ||||
| Approval Date: | Feb 16, 2006 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Mar 30, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
Expired US Patents for NDA 021026
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Mylan | VUSION | miconazole nitrate; petrolatum, white; zinc oxide | OINTMENT;TOPICAL | 021026-001 | Feb 16, 2006 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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