Orange Book product
ZOLPIDEM TARTRATE 5MG
Orange Book ANDA 078055 · SUN PHARMACEUTICAL INDUSTRIES LTD · Discontinued
Key facts
| Proprietary name | ZOLPIDEM TARTRATE |
|---|---|
| Active ingredients | ZOLPIDEM TARTRATE |
| Strength | 5MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA078055 |
| Applicant holder | SUN PHARMACEUTICAL INDUSTRIES LTD |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Apr 23, 2007 |
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.