bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate · Monarch Pharms · NDA 050168, 050169, 050218, 050416, 050479
Cortisporin
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 220938, Orbicular Pharm Tech · 050479-001Approved 27 Aug 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 217803, Amneal · 050479-001Approved 29 Oct 2025Detected 25 Oct 2026Historical import
Products covered · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 050168 · 002 · RLD · discontinued | ointment, topical | 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 050169 · 001 · discontinued | suspension/drops, ophthalmic | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | open |
| 050218 · 001 · RLD · discontinued | cream, topical | 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 050416 · 002 · RLD · discontinued | ointment, ophthalmic | 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 050479 · 001 · RLD · discontinued | solution/drops, otic | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |