Orange Book product
DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
Orange Book ANDA 207551 · AMNEAL PHARMACEUTICALS CO GMBH · Prescription
Key facts
| Proprietary name | DEXMEDETOMIDINE HYDROCHLORIDE |
|---|---|
| Active ingredients | DEXMEDETOMIDINE HYDROCHLORIDE |
| Strength | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | ANDA207551 |
| Applicant holder | AMNEAL PHARMACEUTICALS CO GMBH |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | May 20, 2020 |
At a glance
- 10–99 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.