Orange Book product
NORTREL 1/35-28 0.035MG;1MG
Orange Book ANDA 072696 · BARR LABORATORIES LLC (AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC) · Prescription
Key facts
| Proprietary name | NORTREL 1/35-28 |
|---|---|
| Active ingredients | ETHINYL ESTRADIOL, NORETHINDRONE |
| Strength | 0.035MG;1MG |
| Dosage form | TABLET |
| Route | ORAL-28 |
| Application | ANDA072696 |
| Applicant holder | BARR LABORATORIES LLC (AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC) |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | Feb 28, 1992 |
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.