Orange Book product
DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML
Orange Book ANDA 219470 · ANNORA PHARMA PRIVATE LTD · Prescription
Key facts
| Proprietary name | DIPHENHYDRAMINE HYDROCHLORIDE |
|---|---|
| Active ingredients | DIPHENHYDRAMINE HYDROCHLORIDE |
| Strength | 12.5MG/5ML |
| Dosage form | ELIXIR |
| Route | ORAL |
| Application | ANDA219470 |
| Applicant holder | ANNORA PHARMA PRIVATE LTD |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AA |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Jun 17, 2026 |
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.