FDA Approval Activities for this Drug…

Elavil (amitriptyline hydrochloride) Tablets & Injection, AstraZeneca NDA 12-703/S-093 & 12-704/S-046 7/29/03 8/6/03 Elavil (amitriptyline hydrochloride) Tablets (NDA 12-703) and Injection (NDA 12-704). AstraZeneca NDA 12-704/S-045 & 12-703/S-092 AMITRIPTYLINE HYDROCHLORIDE Injection 10MG/ML ELAVIL ASTRAZENECA 012703 AMITRIPTYLINE HYDROCHLORIDE Tablet; 100MG ELAVIL ASTRAZENECA 012703 AMITRIPTYLINE HYDROCHLORIDE Tablet; 10MG ELAVIL ASTRAZENECA 012703 AMITRIPTYLINE HYDROCHLORIDE Tablet; 150MG ELAVIL ASTRAZENECA 012703 AMITRIPTYLINE HYDROCHLORIDE Tablet; 25MG ELAVIL ASTRAZENECA 012703 AMITRIPTYLINE HYDROCHLORIDE Tablet; 50MG ELAVIL ASTRAZENECA 012703 AMITRIPTYLINE HYDROCHLORIDE Tablet; 75MG ELAVIL ASTRAZENECA 085967 AMITRIPTYLINE HYDROCHLORIDE Tablet; 100MG AMITRIPTYLINE HCL Geneva 085969 AMITRIPTYLINE HYDROCHLORIDE Tablet; 10MG AMITRIPTYLINE HCL Geneva 085970 AMITRIPTYLINE HYDROCHLORIDE Tablet; 150MG AMITRIPTYLINE HCL Geneva 085966 AMITRIPTYLINE HYDROCHLORIDE Tablet; 25MG AMITRIPTYLINE HCL Geneva 085968 AMITRIPTYLINE HYDROCHLORIDE Tablet; 50MG AMITRIPTYLINE HCL Geneva 085971 AMITRIPTYLINE HYDROCHLORIDE Tablet; 75MG AMITRIPTYLINE HCL Geneva 089402 AMITRIPTYLINE HYDROCHLORIDE Tablet; 100MG AMITRIPTYLINE HCL Mutual 089398 AMITRIPTYLINE HYDROCHLORIDE Tablet; 10MG AMITRIPTYLINE HCL Mutual 089403 AMITRIPTYLINE HYDROCHLORIDE Tablet; 150MG AMITRIPTYLINE HCL Mutual 089399 AMITRIPTYLINE HYDROCHLORIDE Tablet; 25MG AMITRIPTYLINE HCL Mutual 089400 AMITRIPTYLINE HYDROCHLORIDE Tablet; 50MG AMITRIPTYLINE HCL Mutual 089401 AMITRIPTYLINE HYDROCHLORIDE Tablet; 75MG AMITRIPTYLINE HCL Mutual 086158 AMITRIPTYLINE HYDROCHLORIDE Tablet; 100MG AMITRIPTYLINE HCL Mylan 086157 AMITRIPTYLINE HYDROCHLORIDE Tablet; 10MG AMITRIPTYLINE HCL Mylan 086153 AMITRIPTYLINE HYDROCHLORIDE Tablet; 150MG AMITRIPTYLINE HCL Mylan 086010 AMITRIPTYLINE HYDROCHLORIDE Tablet; 25MG AMITRIPTYLINE HCL Mylan 086009 AMITRIPTYLINE HYDROCHLORIDE Tablet; 50MG AMITRIPTYLINE HCL Mylan 086011 AMITRIPTYLINE HYDROCHLORIDE Tablet; 75MG AMITRIPTYLINE HCL Mylan 088887 AMITRIPTYLINE HYDROCHLORIDE Tablet; 100MG AMITRIPTYLINE HCL Pliva 088883 AMITRIPTYLINE HYDROCHLORIDE Tablet; 10MG AMITRIPTYLINE HCL Pliva 088888 AMITRIPTYLINE HYDROCHLORIDE Tablet; 150MG AMITRIPTYLINE HCL Pliva 088884 AMITRIPTYLINE HYDROCHLORIDE Tablet; 25MG AMITRIPTYLINE HCL Pliva 088885 AMITRIPTYLINE HYDROCHLORIDE Tablet; 50MG AMITRIPTYLINE HCL Pliva 088886 AMITRIPTYLINE HYDROCHLORIDE Tablet; 75MG AMITRIPTYLINE HCL Pliva 088857 AMITRIPTYLINE HYDROCHLORIDE Tablet; 100MG AMITRIPTYLINE HCL SUPERPHARM 088853 AMITRIPTYLINE HYDROCHLORIDE Tablet; 10MG AMITRIPTYLINE HCL SUPERPHARM 088854 AMITRIPTYLINE HYDROCHLORIDE Tablet; 25MG AMITRIPTYLINE HCL SUPERPHARM 088855 AMITRIPTYLINE HYDROCHLORIDE Tablet; 50MG AMITRIPTYLINE HCL SUPERPHARM 088856 AMITRIPTYLINE HYDROCHLORIDE Tablet; 75MG AMITRIPTYLINE HCL SUPERPHARM 085836 AMITRIPTYLINE HYDROCHLORIDE Tablet; 100MG AMITRIPTYLINE HCL Teva 084910 AMITRIPTYLINE HYDROCHLORIDE Tablet; 10MG AMITRIPTYLINE HCL Teva 085031 AMITRIPTYLINE HYDROCHLORIDE Tablet; 25MG AMITRIPTYLINE HCL Teva 085032 AMITRIPTYLINE HYDROCHLORIDE Tablet; 50MG AMITRIPTYLINE HCL Teva 040218 AMITRIPTYLINE HYDROCHLORIDE Tablet; 100MG AMITRIPTYLINE HYDROCHLORIDE Vintage 040218 AMITRIPTYLINE HYDROCHLORIDE Tablet; 10MG AMITRIPTYLINE HYDROCHLORIDE Vintage 040218 AMITRIPTYLINE HYDROCHLORIDE Tablet; 150MG AMITRIPTYLINE HYDROCHLORIDE Vintage 040218 AMITRIPTYLINE HYDROCHLORIDE Tablet; 25MG AMITRIPTYLINE HYDROCHLORIDE Vintage 040218 AMITRIPTYLINE HYDROCHLORIDE Tablet; 50MG AMITRIPTYLINE HYDROCHLORIDE Vintage 040218 AMITRIPTYLINE HYDROCHLORIDE Tablet; 75MG AMITRIPTYLINE HYDROCHLORIDE Vintage 016949 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE Tablet; 12.5MG BASE;5MG LIMBITROL ICN 016949 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE Tablet; 25MG BASE;10MG LIMBITROL DS ICN 071296 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE Tablet; 12.5MG BASE;5MG CHLORDIAZEPOXIDE AND AMITRIPTYLINE HCL Mylan 071297 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE Tablet; 25MG BASE;10MG CHLORDIAZEPOXIDE AND AMITRIPTYLINE HCL Mylan 072277 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE Tablet; 12.5MG BASE;5MG CHLORDIAZEPOXIDE AND AMITRIPTYLINE HCL Par 072278 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE Tablet; 25MG BASE;10MG CHLORDIAZEPOXIDE AND AMITRIPTYLINE HCL Par 072052 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE Tablet; 12.5MG BASE;5MG CHLORDIAZEPOXIDE AND AMITRIPTYLINE HCL Watson 072053 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE Tablet; 25MG BASE;10MG CHLORDIAZEPOXIDE AND AMITRIPTYLINE HCL Watson 071062 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE Tablet; 10MG;2MG PERPHENAZINE AND AMITRIPTYLINE HCL Geneva 071862 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE Tablet; 10MG;4MG PERPHENAZINE AND AMITRIPTYLINE HCL Geneva 071063 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE Tablet; 25MG;2MG PERPHENAZINE AND AMITRIPTYLINE HCL Geneva 071064 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE Tablet; 25MG;4MG PERPHENAZINE AND AMITRIPTYLINE HCL Geneva 071863 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE Tablet; 50MG;4MG PERPHENAZINE AND AMITRIPTYLINE HCL Geneva 070336 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE Tablet; 10MG;2MG PERPHENAZINE AND AMITRIPTYLINE HCL Mylan 071442 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE Tablet; 10MG;4MG PERPHENAZINE AND AMITRIPTYLINE HCL Mylan 070337 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE Tablet; 25MG;2MG PERPHENAZINE AND AMITRIPTYLINE HCL Mylan 070338 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE Tablet; 25MG;4MG PERPHENAZINE AND AMITRIPTYLINE HCL Mylan 071443 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE Tablet; 50MG;4MG PERPHENAZINE AND AMITRIPTYLINE HCL Mylan 073007 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE Tablet; 10MG;2MG PERPHENAZINE AND AMITRIPTYLINE HCL Watson 073009 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE Tablet; 10MG;4MG PERPHENAZINE AND AMITRIPTYLINE HCL Watson 073008 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE Tablet; 25MG;2MG PERPHENAZINE AND AMITRIPTYLINE HCL Watson 073010 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE Tablet; 25MG;4MG PERPHENAZINE AND AMITRIPTYLINE HCL Watson | Limbitrol (chlordiazepoxide and amitriptyline hydrochloride) Tablets, Valeant Pharma, Labeling Revision

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