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FDA Orange Book · active-ingredient family

Miconazole nitrate; white petrolatum; zinc oxide

Miconazole nitrate; white petrolatum; zinc oxide is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:VUSION · NDA 021026

1

Brand (NDA)

0

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · ointment

ProductApplicantApplicationTEApproved
VUSIONRLDMYLANNDA 021026—Feb 16, 2006

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8147852Mar 30, 2028in 1 yr 10 mo
U-1426

Miconazole nitrate; white petrolatum; zinc oxide — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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