rocuronium bromide · Organon Usa Inc · NDA 020214
Zemuron
Earliest generic entry, as listed · earliest of 3 marketed strengths
Open now
No marketed reference-listed strength; date taken from all listed strengths.
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
- Generic approved · ANDA 220124, Aspiro · 020214-001Approved 4 Mar 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 213476, Knack · 020214-001Approved 6 Jan 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219260, Baxter Hlthcare Corp · 020214-001Approved 18 Sep 2026Detected 25 Oct 2026Historical import
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 020214 · 001 · RLD · discontinued | injectable, injection | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020214 · 002 · RLD · discontinued | injectable, injection | 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020214 · 003 · RLD · discontinued | injectable, injection | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |