Orange Book product · Generic (ANDA)
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE
At a glance
Jan 12, 1988
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 12, 1988
39 yr ago
Today
Pharmaceutical detail
Active ingredient
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE
Strength
EQ 12.5MG BASE;5MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 070477
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE
- —LIMBITROLBrand (NDA)
NDA 016949 · CHARTWELL RX
- 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 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.
