Orange Book product
MONO-LINYAH 0.035MG;0.25MG
Orange Book ANDA 090523 · NOVAST LABORATORIES LTD · Prescription
Key facts
| Proprietary name | MONO-LINYAH |
|---|---|
| Active ingredients | ETHINYL ESTRADIOL, NORGESTIMATE |
| Strength | 0.035MG;0.25MG |
| Dosage form | TABLET |
| Route | ORAL-28 |
| Application | ANDA090523 |
| Applicant holder | NOVAST LABORATORIES LTD |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | May 23, 2012 |
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.