Orange Book product
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE EQ 0.5MG BASE;EQ 50MG BASE
Orange Book ANDA 075523 · SUN PHARMACEUTICAL INDUSTRIES LTD · Prescription
Key facts
| Proprietary name | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE |
|---|---|
| Active ingredients | NALOXONE HYDROCHLORIDE, PENTAZOCINE HYDROCHLORIDE |
| Strength | EQ 0.5MG BASE;EQ 50MG BASE |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA075523 |
| Applicant holder | SUN PHARMACEUTICAL INDUSTRIES LTD |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Mar 17, 2000 |
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.