sertraline hydrochloride · Almatica · NDA 215133
Sertraline Hydrochloride
Earliest generic entry, as listed · earliest of 2 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
- Generic approved · ANDA 218342, Umedica · 215133-001Approved 20 Jan 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 218712, Appco · 215133-001Approved 20 Jan 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219714, Novitium Pharma · 215133-001Approved 20 Jan 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219655, Amneal · 215133-001Approved 28 Jan 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 220275, Zydus Lifesciences · 215133-001Approved 29 Jan 2026Detected 25 Oct 2026Historical import
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 215133 · 001 · RLD | capsule, oral | EQ 150MG BASE | open |
| 215133 · 002 · RLD | capsule, oral | EQ 200MG BASE | open |