Application 086009

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No
002	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
003	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No
004	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	75MG	No	No
005	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	100MG	No	No
006	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	150MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-2610	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2610	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2625	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2625	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2650	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2650	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2675	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2675	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2685	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2685	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2695	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2695	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
50090-2972	Amitriptyline Hydrochloride	amitriptyline hydrochloride	A-S Medication Solutions	ANDA	Current
51079-107	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-107	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-107	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-107	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-131	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-131	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-131	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-131	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-133	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-133	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-133	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-133	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-147	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-147	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-147	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-563	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-563	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-563	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Mylan Institutional Inc.	ANDA	Current
55154-5665	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Cardinal Health	ANDA	Current
55154-5665	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Cardinal Health	ANDA	Current
61919-013	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	Direct Rx	ANDA	Current
61919-013	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	Direct Rx	ANDA	Current
63629-6311	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-6311	Amitriptyline Hydrochloride	amitriptyline hydrochloride	Bryant Ranch Prepack	ANDA	Current
67296-1245	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1245	Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	RedPharm Drug, Inc.	ANDA	Current

Application 086009

Related Records#

Application Products#

NDC Listings For This Application#