Orange Book product
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML
Orange Book ANDA 207487 · ABHAI LLC · Prescription
Key facts
| Proprietary name | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE |
|---|---|
| Active ingredients | HOMATROPINE METHYLBROMIDE, HYDROCODONE BITARTRATE |
| Strength | 1.5MG/5ML;5MG/5ML |
| Dosage form | SYRUP |
| Route | ORAL |
| Application | ANDA207487 |
| Applicant holder | ABHAI LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AA |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | Feb 21, 2017 |
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.