Orange Book product
INNOPRAN XL 80MG
Orange Book NDA 021438 · ANI PHARMACEUTICALS INC · Prescription
Key facts
| Proprietary name | INNOPRAN XL |
|---|---|
| Active ingredients | PROPRANOLOL HYDROCHLORIDE |
| Strength | 80MG |
| Dosage form | CAPSULE, EXTENDED RELEASE |
| Route | ORAL |
| Application | NDA021438 |
| Applicant holder | ANI PHARMACEUTICALS INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | BX |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | No |
| Approval date | Mar 12, 2003 |
At a glance
- 10–99 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- Yes 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.