Orange Book product
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 0.025MG;2.5MG
Orange Book ANDA 213413 · LEADING PHARMA LLC · Prescription
Key facts
| Proprietary name | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE |
|---|---|
| Active ingredients | ATROPINE SULFATE, DIPHENOXYLATE HYDROCHLORIDE |
| Strength | 0.025MG;2.5MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA213413 |
| Applicant holder | LEADING PHARMA LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AA |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Feb 20, 2020 |
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.