ciprofloxacin hydrochloride · Bayer Hlthcare · NDA 019537, 019847, 020780
Cipro
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 · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 019537 · 002 · RLD | tablet, oral | EQ 250MG BASE | open |
| 019537 · 003 · RLD | tablet, oral | EQ 500MG BASE | open |
| 019537 · 004 · RLD · discontinued | tablet, oral | EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 019847 · 001 · RLD · discontinued | injectable, injection | 400MG/40ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 019847 · 002 · RLD · discontinued | injectable, injection | 200MG/20ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 019847 · 003 · discontinued | injectable, injection | 1200MG/120ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020780 · 001 · RLD | for suspension, oral | 250MG/5ML | open |
| 020780 · 002 · RLD | for suspension, oral | 500MG/5ML | open |