Orange Book product · Brand (NDA)
LIMBITROL
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE
Strength
EQ 12.5MG BASE;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 016949
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2022CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 211925 · MICRO LABS
- 1988CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 072052 · HERITAGE PHARMA
- 1988CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 072053 · HERITAGE PHARMA
- 1988CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 072277 · CHARTWELL RX
- 1988CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 072278 · CHARTWELL RX
- 1988CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 070477 · USL PHARMA
- 1988CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 070478 · USL PHARMA
- 1986CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 071297 · MYLAN PHARMS INC
- 1986CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 070765 · TP ANDA HOLDINGS
- 1986CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 070766 · TP ANDA HOLDINGS
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.
