Orange Book product
HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG
Orange Book ANDA 040826 · SUN PHARMACEUTICAL INDUSTRIES LTD · Discontinued
Key facts
| Proprietary name | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
|---|---|
| Active ingredients | ACETAMINOPHEN, HYDROCODONE BITARTRATE |
| Strength | 325MG;10MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA040826 |
| Applicant holder | SUN PHARMACEUTICAL INDUSTRIES LTD |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Aug 16, 2007 |
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.