dicyclomine hydrochloride · Allergan · NDA 007409, 007961, 008370
Bentyl
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 216515, Rubicon Research · 007409-003Approved 17 Jul 2026Detected 25 Oct 2026Historical import
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 007409 · 001 · RLD · discontinued | tablet, oral | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 007409 · 003 · RLD · discontinued | capsule, oral | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 007961 · 002 · RLD · discontinued | syrup, oral | 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 008370 · 001 · RLD · discontinued | injectable, injection | 10MG/ML | open |