Orange Book product
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG
Orange Book ANDA 073209 · RISING PHARMA HOLDING INC · Prescription
Key facts
| Proprietary name | AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE |
|---|---|
| Active ingredients | AMILORIDE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE |
| Strength | EQ 5MG ANHYDROUS;50MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA073209 |
| Applicant holder | RISING PHARMA HOLDING INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | Oct 31, 1991 |
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.