Application 086513

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; SPIRONOLACTONE	TABLET;ORAL	25MG;25MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0141	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0141	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Mylan Pharmaceuticals Inc	ANDA	Current
0378-0403	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0403	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0403	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0403	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0403	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0403	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0403	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
42292-017	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Mylan Institutional Inc.	ANDA	Current
42292-017	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Mylan Institutional Inc.	ANDA	Current
42292-017	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Mylan Institutional Inc.	ANDA	Current