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FDA Orange Book · active-ingredient family

Retapamulin

Retapamulin is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:ALTABAX · NDA 022055

1

Brand (NDA)

0

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · ointment

ProductApplicantApplicationTEApproved
ALTABAXRLDALMIRALLNDA 022055Apr 12, 2007

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7875630Feb 14, 2027in 8 mo
Substance

Retapamulin — frequently asked questions

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

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.