Orange Book product
GILDESS 1.5/30 0.03MG;1.5MG
Orange Book ANDA 077075 · PH HEALTH LTD · Discontinued
Key facts
| Proprietary name | GILDESS 1.5/30 |
|---|---|
| Active ingredients | ETHINYL ESTRADIOL, NORETHINDRONE ACETATE |
| Strength | 0.03MG;1.5MG |
| Dosage form | TABLET |
| Route | ORAL-21 |
| Application | ANDA077075 |
| Applicant holder | PH HEALTH LTD |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Jul 24, 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.