propranolol hydrochloride · Ani Pharms · NDA 021438
Innopran Xl
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 217238, Micro Labs · 021438-001Approved 24 Jun 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219460, Creekwood Pharms · 021438-001Approved 14 Aug 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 203103, Ipca Labs Ltd · 021438-001Approved 1 May 2026Detected 25 Oct 2026Historical import
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021438 · 001 · RLD | capsule, extended release, oral | 80MG | open |
| 021438 · 002 · RLD | capsule, extended release, oral | 120MG | open |