Orange Book product
NORETHINDRONE AND ETHINYL ESTRADIOL 0.035MG;1MG
Orange Book ANDA 070687 · WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC · Prescription
Key facts
| Proprietary name | NORETHINDRONE AND ETHINYL ESTRADIOL |
|---|---|
| Active ingredients | ETHINYL ESTRADIOL, NORETHINDRONE |
| Strength | 0.035MG;1MG |
| Dosage form | TABLET |
| Route | ORAL-28 |
| Application | ANDA070687 |
| Applicant holder | WATSON LABORATORIES INC 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 | Jan 29, 1987 |
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.