Orange Book product
PROPARACAINE HYDROCHLORIDE 0.5%
Orange Book ANDA 219294 · MICRO LABS LTD · Prescription
Key facts
| Proprietary name | PROPARACAINE HYDROCHLORIDE |
|---|---|
| Active ingredients | PROPARACAINE HYDROCHLORIDE |
| Strength | 0.5% |
| Dosage form | SOLUTION/DROPS |
| Route | OPHTHALMIC |
| Application | ANDA219294 |
| Applicant holder | MICRO LABS LTD |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AT |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Oct 20, 2025 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.