procainamide hydrochloride · Apothecon · NDA 007335, 017371
Pronestyl
Earliest generic entry, as listed · earliest of 5 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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 8
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 007335 · 001 · RLD · discontinued | capsule, oral | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 007335 · 002 · RLD · discontinued | injectable, injection | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 007335 · 003 · RLD · discontinued | capsule, oral | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 007335 · 004 · RLD · discontinued | capsule, oral | 375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 007335 · 005 · RLD · discontinued | injectable, injection | 500MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 017371 · 001 · discontinued | tablet, oral | 250MG | open |
| 017371 · 002 · discontinued | tablet, oral | 375MG | open |
| 017371 · 003 · discontinued | tablet, oral | 500MG | open |