Orange Book product
DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML
Orange Book ANDA 088680 · NASKA PHARMACAL CO INC DIV RUGBY DARBY GROUP COSMETICS · Discontinued
Key facts
| Proprietary name | DIPHENHYDRAMINE HYDROCHLORIDE |
|---|---|
| Active ingredients | DIPHENHYDRAMINE HYDROCHLORIDE |
| Strength | 12.5MG/5ML |
| Dosage form | ELIXIR |
| Route | ORAL |
| Application | ANDA088680 |
| Applicant holder | NASKA PHARMACAL CO INC DIV RUGBY DARBY GROUP COSMETICS |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | May 31, 1985 |
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.