Orange Book product
TRI-NORINYL 28-DAY 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG
Orange Book NDA 018977 · DR REDDYS LABORATORIES SA · Prescription
Key facts
| Proprietary name | TRI-NORINYL 28-DAY |
|---|---|
| Active ingredients | ETHINYL ESTRADIOL, NORETHINDRONE |
| Strength | 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG |
| Dosage form | TABLET |
| Route | ORAL-28 |
| Application | NDA018977 |
| Applicant holder | DR REDDYS LABORATORIES SA |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | Yes |
| Approval date | Apr 13, 1984 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- Yes 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.