Drug application
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE (NAPHAZOLINE HYDROCHLORIDE, PHENIRAMINE MALEATE)
Drugs@FDA ANDA 078208 · ALTAIRE PHARMS INC
Key facts
| Drug name | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE |
|---|---|
| Active ingredients | NAPHAZOLINE HYDROCHLORIDE, PHENIRAMINE MALEATE |
| Application type | ANDA |
| Application number | 078208 |
| Company | ALTAIRE PHARMS INC |
| Dosage forms | SOLUTION/DROPS, OPHTHALMIC |
| Strength | 0.02675%;0.315% |
| Marketing status | Over-the-counter |
| Reference listed drug | No |
| Latest submission status date | Sep 27, 2010 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- None Therapeutic equivalents
- No FDA letters on file
- Yes FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: