Orange Book product
ACEBUTOLOL HYDROCHLORIDE EQ 200MG BASE
Orange Book ANDA 075047 · AMNEAL PHARMACEUTICAL · Prescription
Key facts
| Proprietary name | ACEBUTOLOL HYDROCHLORIDE |
|---|---|
| Active ingredients | ACEBUTOLOL HYDROCHLORIDE |
| Strength | EQ 200MG BASE |
| Dosage form | CAPSULE |
| Route | ORAL |
| Application | ANDA075047 |
| Applicant holder | AMNEAL PHARMACEUTICAL |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | Dec 30, 1999 |
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.