Orange Book product
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG
Orange Book ANDA 090938 · BARR LABORATORIES LLC (AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC) · Prescription
Key facts
| Proprietary name | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE |
|---|---|
| Active ingredients | ETHINYL ESTRADIOL, NORETHINDRONE ACETATE |
| Strength | 0.02MG;1MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA090938 |
| 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) | No |
| Approval date | Dec 1, 2014 |
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.