Orange Book product
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.035MG;0.4MG
Orange Book ANDA 078892 · AMNEAL PHARMACEUTICALS OF NEW YORK LLC · Prescription
Key facts
| Proprietary name | NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE |
|---|---|
| Active ingredients | ETHINYL ESTRADIOL, NORETHINDRONE |
| Strength | 0.035MG;0.4MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA078892 |
| Applicant holder | AMNEAL PHARMACEUTICALS OF NEW YORK LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Sep 26, 2011 |
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.