Orange Book product
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE 60MG;1.2GM
Orange Book ANDA 091070 · ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC · Over the counter
Key facts
| Proprietary name | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE |
|---|---|
| Active ingredients | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN |
| Strength | 60MG;1.2GM |
| Dosage form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Application | ANDA091070 |
| Applicant holder | ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC |
| Marketing status | Over the counter |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Aug 31, 2015 |
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.