Orange Book product
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE 10MG;25MG
Orange Book ANDA 075727 · COSETTE PHARMACEUTICALS NC LABORATORIES LLC · Discontinued
Key facts
| Proprietary name | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE |
|---|---|
| Active ingredients | ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDE |
| Strength | 10MG;25MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA075727 |
| Applicant holder | COSETTE PHARMACEUTICALS NC LABORATORIES LLC |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Sep 18, 2001 |
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.