ammonium lactate · Sun Pharm Inds Inc · NDA 019155, 020508
Lac-Hydrin
Earliest generic entry, as listed · earliest of 2 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 217758, Zydus Lifesciences · 019155-001Approved 15 May 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 217815, Zydus Lifesciences · 020508-001Approved 12 Feb 2026Detected 25 Oct 2026Historical import
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 019155 · 001 · RLD · discontinued | lotion, topical | EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020508 · 001 · RLD · discontinued | cream, topical | EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |