diclofenac sodium · Novartis · NDA 019201, 020037
Voltaren
Earliest generic entry, as listed · earliest of 4 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 219945, Umedica · 019201-001Approved 5 Nov 2025Detected 25 Oct 2026Historical import
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 019201 · 001 · RLD · discontinued | tablet, delayed release, oral | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 019201 · 002 · RLD · discontinued | tablet, delayed release, oral | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 019201 · 003 · RLD · discontinued | tablet, delayed release, oral | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020037 · 001 · RLD · discontinued | solution/drops, ophthalmic | 0.1% | open |