Orange Book product
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE EQ 12.5MG BASE;5MG
Orange Book ANDA 070765 · TP ANDA HOLDINGS LLC · Discontinued
Key facts
| Proprietary name | CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE |
|---|---|
| Active ingredients | AMITRIPTYLINE HYDROCHLORIDE, CHLORDIAZEPOXIDE |
| Strength | EQ 12.5MG BASE;5MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA070765 |
| Applicant holder | TP ANDA HOLDINGS LLC |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Dec 10, 1986 |
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.