azithromycin · Pfizer · NDA 050670, 050693, 050710, 050711, 050730, 050733, 050784

Zithromax

Earliest generic entry, as listed · earliest of 4 marketed strengths
Open now

No unexpired patents or exclusivities are listed for this product.

Listed patents · 0 unexpired

No unexpired patents listed.

Exclusivities · 0 unexpired

No unexpired exclusivities listed.

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.

Products covered · 8

NDA · productFormStrengthListed expiry
050670 · 001 · RLD · discontinuedcapsule, oralEQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**open
050693 · 001 · RLD · discontinuedfor suspension, oralEQ 1GM BASE/PACKETopen
050710 · 001 · RLDfor suspension, oralEQ 100MG BASE/5MLopen
050710 · 002 · RLDfor suspension, oralEQ 200MG BASE/5MLopen
050711 · 001 · RLDtablet, oralEQ 250MG BASEopen
050730 · 001 · RLD · discontinuedtablet, oralEQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**open
050733 · 001 · RLD · discontinuedinjectable, injectionEQ 500MG BASE/VIALopen
050784 · 001 · RLDtablet, oralEQ 500MG BASEopen