atropine sulfate · Hospira · NDA 020056, 021146, 206289, 209260, 213581, 214652
Atropine Sulfate
Earliest generic entry, as listed · earliest of 8 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
- 25 Oct 2026Generic approved · 206289-00116 Oct 2026
- 25 Oct 2026Generic approved · 213581-00115 Apr 2026
- 25 Oct 2026Generic approved · 213581-00131 Jul 2026
- 25 Oct 2026Generic approved · 021146-00124 Oct 2025
- 25 Oct 2026Generic approved · 213581-00116 Oct 2026
Products covered · 9
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 020056 · 001 · discontinued | aerosol, metered, inhalation | EQ 0.36MG BASE/INH | open |
| 021146 · 001 · RLD | solution, intravenous | 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 021146 · 002 · RLD | solution, intravenous | 0.25MG/5ML (0.05MG/ML) | open |
| 021146 · 003 · RLD | solution, intravenous | 1MG/10ML (0.1MG/ML) | open |
| 206289 · 001 · RLD | solution/drops, ophthalmic | 1% | open |
| 209260 · 001 · RLD | solution, intravenous, intramuscular, subcutaneous, intraosseous, endotracheal | 8MG/20ML (0.4MG/ML) | open |
| 213581 · 001 · RLD | solution/drops, ophthalmic | 1% | open |
| 214652 · 001 · RLD | solution, intravenous | 0.4MG/ML (0.4MG/ML) | open |
| 214652 · 002 · RLD | solution, intravenous | 1MG/ML (1MG/ML) | open |