Orange Book product
PROCAINAMIDE HYDROCHLORIDE 1GM
Orange Book ANDA 040111 · ANI PHARMACEUTICALS INC · Discontinued
Key facts
| Proprietary name | PROCAINAMIDE HYDROCHLORIDE |
|---|---|
| Active ingredients | PROCAINAMIDE HYDROCHLORIDE |
| Strength | 1GM |
| Dosage form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Application | ANDA040111 |
| Applicant holder | ANI PHARMACEUTICALS INC |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Dec 13, 1996 |
At a glance
- None 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.