Orange Book product
PROMETHAZINE HYDROCHLORIDE 12.5MG
Orange Book ANDA 216446 · ANNORA PHARMA PRIVATE LTD · Prescription
Key facts
| Proprietary name | PROMETHAZINE HYDROCHLORIDE |
|---|---|
| Active ingredients | PROMETHAZINE HYDROCHLORIDE |
| Strength | 12.5MG |
| Dosage form | SUPPOSITORY |
| Route | RECTAL |
| Application | ANDA216446 |
| Applicant holder | ANNORA PHARMA PRIVATE LTD |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Nov 2, 2022 |
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.