Orange Book product
HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG
Orange Book ANDA 091528 · NOVEL LABORATORIES INC · Discontinued
Key facts
| Proprietary name | HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE |
|---|---|
| Active ingredients | HOMATROPINE METHYLBROMIDE, HYDROCODONE BITARTRATE |
| Strength | 1.5MG;5MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA091528 |
| Applicant holder | NOVEL LABORATORIES INC |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Apr 20, 2011 |
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.