propranolol hydrochloride · Wyeth Pharms · NDA 016418, 019536
Inderal
Earliest generic entry, as listed · earliest of 6 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 216663, Mankind Pharma · 016418-001Approved 27 Jan 2026Detected 25 Oct 2026Historical import
Products covered · 7
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 016418 · 001 · RLD · discontinued | tablet, oral | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 016418 · 002 · RLD · discontinued | tablet, oral | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 016418 · 003 · RLD · discontinued | tablet, oral | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 016418 · 004 · RLD · discontinued | tablet, oral | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 016418 · 009 · RLD · discontinued | tablet, oral | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 016418 · 010 · RLD · discontinued | tablet, oral | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 019536 · 001 · discontinued | suspension, oral | 10MG/ML | open |