Orange Book product
HYDROCODONE BITARTRATE AND ACETAMINOPHEN 300MG;5MG
Orange Book ANDA 207709 · AUROLIFE PHARMA LLC · Prescription
Key facts
| Proprietary name | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
|---|---|
| Active ingredients | ACETAMINOPHEN, HYDROCODONE BITARTRATE |
| Strength | 300MG;5MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA207709 |
| Applicant holder | AUROLIFE PHARMA LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AA |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Sep 13, 2018 |
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.