Orange Book product
CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML
Orange Book ANDA 074075 · ACTAVIS MID ATLANTIC LLC · Discontinued
Key facts
| Proprietary name | CLEMASTINE FUMARATE |
|---|---|
| Active ingredients | CLEMASTINE FUMARATE |
| Strength | EQ 0.5MG BASE/5ML |
| Dosage form | SYRUP |
| Route | ORAL |
| Application | ANDA074075 |
| Applicant holder | ACTAVIS MID ATLANTIC LLC |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Oct 31, 1993 |
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.