Orange Book product
SUDAFED 12 HOUR 120MG
Orange Book ANDA 073585 · MCNEIL CONSUMER HEALTHCARE · Discontinued
Key facts
| Proprietary name | SUDAFED 12 HOUR |
|---|---|
| Active ingredients | PSEUDOEPHEDRINE HYDROCHLORIDE |
| Strength | 120MG |
| Dosage form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Application | ANDA073585 |
| Applicant holder | MCNEIL CONSUMER HEALTHCARE |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| 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.