Application 018823

Type: NDA
Sponsor: HIKMA

Related Records

Company: HIKMA

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FUROSEMIDE	FUROSEMIDE	TABLET;ORAL	20MG	No	No
002	FUROSEMIDE	FUROSEMIDE	TABLET;ORAL	40MG	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-4297	Furosemide	Furosemide	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-4297	Furosemide	Furosemide	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-4297	Furosemide	Furosemide	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-4299	Furosemide	Furosemide	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-4299	Furosemide	Furosemide	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-4299	Furosemide	Furosemide	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-8297	Furosemide	Furosemide	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-8297	Furosemide	Furosemide	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-8297	Furosemide	Furosemide	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-8299	Furosemide	Furosemide	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-8299	Furosemide	Furosemide	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-8299	Furosemide	Furosemide	West-Ward Pharmaceuticals Corp.	NDA	Current
0615-7937	Furosemide	Furosemide	NCS HealthCare of KY, Inc dba Vangard Labs	NDA	Current
0615-7937	Furosemide	Furosemide	NCS HealthCare of KY, Inc dba Vangard Labs	NDA	Current
0615-7938	Fuosemide	Furosemide	NCS HealthCare of KY, Inc dba Vangard Labs	NDA	Current
0615-7938	Fuosemide	Furosemide	NCS HealthCare of KY, Inc dba Vangard Labs	NDA	Current
43353-069	Furosemide	Furosemide	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
43353-747	Furosemide	Furosemide	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
50090-2951	Furosemide	Furosemide	A-S Medication Solutions	NDA	Current
50090-2951	Furosemide	Furosemide	A-S Medication Solutions	NDA	Current
50090-2951	Furosemide	Furosemide	A-S Medication Solutions	NDA	Current
50090-3262	Furosemide	Furosemide	A-S Medication Solutions	NDA	Current
50090-3262	Furosemide	Furosemide	A-S Medication Solutions	NDA	Current
50090-4109	Furosemide	Furosemide	A-S Medication Solutions	NDA	Current
50090-4111	Furosemide	Furosemide	A-S Medication Solutions	NDA	Current
50090-4111	Furosemide	Furosemide	A-S Medication Solutions	NDA	Current
50090-6219	Furosemide	Furosemide	A-S Medication Solutions	NDA	Current
50090-6221	Furosemide	Furosemide	A-S Medication Solutions	NDA	Current
51407-113	Furosemide	Furosemide	Golden State Medical Supply Inc.	NDA	Current
51407-113	Furosemide	Furosemide	Golden State Medical Supply Inc.	NDA	Current
51407-113	Furosemide	Furosemide	Golden State Medical Supply	NDA	Current
51407-113	Furosemide	Furosemide	Golden State Medical Supply, Inc.	NDA	Current
51407-114	Furosemide	Furosemide	Golden State Medical Supply Inc.	NDA	Current
51407-114	Furosemide	Furosemide	Golden State Medical Supply Inc.	NDA	Current
51407-114	Furosemide	Furosemide	Golden State Medical Supply	NDA	Current
51407-114	Furosemide	Furosemide	Golden State Medical Supply, Inc.	NDA	Current
68788-1966	Furosemide	Furosemide	Preferred Pharmaceuticals, Inc.	NDA	Current
70518-0809	Furosemide	Furosemide	REMEDYREPACK INC.	NDA	Current
70518-0809	Furosemide	Furosemide	REMEDYREPACK INC.	NDA	Current
70518-0809	Furosemide	Furosemide	REMEDYREPACK INC.	NDA	Current
70518-0809	Furosemide	Furosemide	REMEDYREPACK INC.	NDA	Current
70518-0836	Furosemide	Furosemide	REMEDYREPACK INC.	NDA	Current
70518-0836	Furosemide	Furosemide	REMEDYREPACK INC.	NDA	Current
70518-0836	Furosemide	Furosemide	REMEDYREPACK INC.	NDA	Current
70518-0836	Furosemide	Furosemide	REMEDYREPACK INC.	NDA	Current
70934-412	Furosemide	Furosemide	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	NDA	Current
70934-412	Furosemide	Furosemide	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	NDA	Current
70934-412	Furosemide	Furosemide	Denton Pharma, Inc. dba Northwind Pharmaceuticals	NDA	Current
70934-737	Furosemide	Furosemide	Denton Pharma, Inc. dba Northwind Pharmaceuticals	NDA	Current
71610-308	Furosemide	Furosemide	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
71610-309	Furosemide	Furosemide	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current

Documents

Document	Submission type	Date
49011	SUPPL	2017-07-18
49004	SUPPL	2017-07-17