Orange Book product
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE 0.02675%;0.315%
Orange Book ANDA 078208 · ALTAIRE PHARMACEUTICALS INC · Over the counter
Key facts
| Proprietary name | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE |
|---|---|
| Active ingredients | NAPHAZOLINE HYDROCHLORIDE, PHENIRAMINE MALEATE |
| Strength | 0.02675%;0.315% |
| Dosage form | SOLUTION/DROPS |
| Route | OPHTHALMIC |
| Application | ANDA078208 |
| Applicant holder | ALTAIRE PHARMACEUTICALS INC |
| Marketing status | Over the counter |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Sep 27, 2010 |
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.