FDA Orange Book · active-ingredient family
Amitriptyline hydrochloride; chlordiazepoxide
Amitriptyline hydrochloride; chlordiazepoxide is approved as 1 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LIMBITROL · NDA 016949
1
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LIMBITROLRLD×2 | CHARTWELL RX | NDA 016949 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE×2 | MICRO LABS | ANDA 211925 | — | Feb 02, 2022 | |
| CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | HERITAGE PHARMA | ANDA 072052 | — | Dec 16, 1988 | |
| CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | HERITAGE PHARMA | ANDA 072053 | — | Dec 16, 1988 | |
| CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | CHARTWELL RX | ANDA 072277 | — | May 09, 1988 | |
| CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | CHARTWELL RX | ANDA 072278 | — | May 09, 1988 | |
| CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | USL PHARMA | ANDA 070477 | — | Jan 12, 1988 | |
| CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | USL PHARMA | ANDA 070478 | — | Jan 12, 1988 | |
| CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE×2 | MYLAN PHARMS INC | ANDA 071297 | — | Dec 10, 1986 | |
| CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | TP ANDA HOLDINGS | ANDA 070765 | — | Dec 10, 1986 | |
| CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | TP ANDA HOLDINGS | ANDA 070766 | — | Dec 10, 1986 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Amitriptyline hydrochloride; chlordiazepoxide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
