Orange Book product · Brand (NDA)
ELAVIL
AMITRIPTYLINE HYDROCHLORIDE
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
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 012703
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.
- —ELAVILBrand (NDA)
NDA 012704 · ASTRAZENECA
- 2022AMITRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 216243 · BRECKENRIDGE
- 2021AMITRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 212654 · AIPING PHARM INC
- 2021AMITRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 213999 · MANKIND PHARMA
- 2014AMITRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 202446 · ACCORD HLTHCARE
- 1987AMITRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 089423 · MUTUAL PHARM
- 1984AMITRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 088672 · AM THERAP
- 1984AMITRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 088673 · AM THERAP
- 1984AMITRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 088674 · AM THERAP
- 1984AMITRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 088675 · AM THERAP
- 1984AMITRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 088697 · PAR PHARM
- 1984AMITRIPTYLINE HYDROCHLORIDEGeneric (ANDA)
ANDA 088421 · COPLEY PHARM
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.
