Application 078155

Type: ANDA
Sponsor: ACCORD HLTHCARE

Related Records

Company: ACCORD HLTHCARE

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SIMVASTATIN	SIMVASTATIN	TABLET;ORAL	80MG	No	No
002	SIMVASTATIN	SIMVASTATIN	TABLET;ORAL	10MG	No	No
003	SIMVASTATIN	SIMVASTATIN	TABLET;ORAL	20MG	No	No
004	SIMVASTATIN	SIMVASTATIN	TABLET;ORAL	40MG	No	No
005	SIMVASTATIN	SIMVASTATIN	TABLET;ORAL	5MG	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0179-0240	simvastatin	simvastatin	KAISER FOUNDATION HOSPITALS	ANDA	Current
0179-0241	simvastatin	simvastatin	KAISER FOUNDATION HOSPITALS	ANDA	Current
0179-0242	simvastatin	simvastatin	KAISER FOUNDATION HOSPITALS	ANDA	Current
0179-0243	simvastatin	simvastatin	KAISER FOUNDATION HOSPITALS	ANDA	Current
10544-907	simvastatin	simvastatin	Blenheim Pharmacal, Inc.	ANDA	Current
10544-908	simvastatin	simvastatin	Blenheim Pharmacal, Inc.	ANDA	Current
16729-004	simvastatin	simvastatin	Accord Healthcare, Inc.	ANDA	Current
16729-004	simvastatin	simvastatin	Accord Healthcare, Inc.	ANDA	Current
16729-004	simvastatin	simvastatin	Accord Healthcare, Inc.	ANDA	Current
16729-004	simvastatin	simvastatin	Accord Healthcare, Inc.	ANDA	Current
16729-004	simvastatin	simvastatin	Accord Healthcare, Inc.	ANDA	Current
16729-004	simvastatin	simvastatin	Accord Healthcare, Inc.	ANDA	Current
16729-005	simvastatin	simvastatin	Accord Healthcare, Inc.	ANDA	Current
16729-005	simvastatin	simvastatin	Accord Healthcare, Inc.	ANDA	Current
16729-005	simvastatin	simvastatin	Accord Healthcare, Inc.	ANDA	Current
16729-005	simvastatin	simvastatin	Accord Healthcare, Inc.	ANDA	Current
16729-005	simvastatin	simvastatin	Accord Healthcare, Inc.	ANDA	Current
16729-005	simvastatin	simvastatin	Accord Healthcare, Inc.	ANDA	Current
16729-006	simvastatin	simvastatin	Accord Healthcare, Inc.	ANDA	Current
16729-006	simvastatin	simvastatin	Accord Healthcare, Inc.	ANDA	Current
16729-006	simvastatin	simvastatin	Accord Healthcare, Inc.	ANDA	Current
16729-006	simvastatin	simvastatin	Accord Healthcare, Inc.	ANDA	Current
16729-006	simvastatin	simvastatin	Accord Healthcare, Inc.	ANDA	Current
16729-006	simvastatin	simvastatin	Accord Healthcare, Inc.	ANDA	Current
16729-007	simvastatin	simvastatin	Accord Healthcare, Inc.	ANDA	Current
16729-007	simvastatin	simvastatin	Accord Healthcare, Inc.	ANDA	Current
16729-007	simvastatin	simvastatin	Accord Healthcare, Inc.	ANDA	Current
16729-007	simvastatin	simvastatin	Accord Healthcare, Inc.	ANDA	Current
16729-007	simvastatin	simvastatin	Accord Healthcare, Inc.	ANDA	Current
16729-007	simvastatin	simvastatin	Accord Healthcare, Inc.	ANDA	Current
16729-156	simvastatin	simvastatin	Accord Healthcare, Inc.	ANDA	Current
16729-156	simvastatin	simvastatin	Accord Healthcare, Inc.	ANDA	Current
16729-156	simvastatin	simvastatin	Accord Healthcare, Inc.	ANDA	Current
16729-156	simvastatin	simvastatin	Accord Healthcare, Inc.	ANDA	Current
16729-156	simvastatin	simvastatin	Accord Healthcare, Inc.	ANDA	Current
16729-156	simvastatin	simvastatin	Accord Healthcare, Inc.	ANDA	Current
33261-541	simvastatin	simvastatin	Aidarex Pharmaceuticals LLC	ANDA	Current
33261-542	simvastatin	simvastatin	Aidarex Pharmaceuticals LLC	ANDA	Current
33261-546	simvastatin	simvastatin	Aidarex Pharmaceuticals LLC	ANDA	Current
33358-431	simvastatin	simvastatin	RxChange Co.	ANDA	Current
33358-475	simvastatin	simvastatin	RxChange Co.	ANDA	Current
42254-032	simvastatin	simvastatin	Rebel Distributors Corp	ANDA	Current
42254-060	simvastatin	simvastatin	Rebel Distributors Corp	ANDA	Current
42254-129	simvastatin	simvastatin	Rebel Distributors Corp	ANDA	Current
42254-168	simvastatin	simvastatin	Rebel Distributors Corp	ANDA	Current
42708-148	simvastatin	simvastatin	QPharma Inc	ANDA	Current
43063-008	simvastatin	simvastatin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-008	simvastatin	simvastatin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-008	simvastatin	simvastatin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-008	simvastatin	simvastatin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-008	simvastatin	simvastatin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-008	simvastatin	simvastatin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-008	simvastatin	simvastatin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-008	simvastatin	simvastatin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-726	simvastatin	simvastatin	PD-Rx Pharmaceuticals, In	ANDA	Current
43063-726	simvastatin	simvastatin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-726	simvastatin	simvastatin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-726	simvastatin	simvastatin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-726	simvastatin	simvastatin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-726	simvastatin	simvastatin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-726	simvastatin	simvastatin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-727	simvastatin	simvastatin	PD-Rx Pharmaceuticals, In	ANDA	Current
43063-727	simvastatin	simvastatin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-727	simvastatin	simvastatin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-727	simvastatin	simvastatin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-727	simvastatin	simvastatin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-727	simvastatin	simvastatin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-727	simvastatin	simvastatin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-733	simvastatin	simvastatin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-733	simvastatin	simvastatin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-733	simvastatin	simvastatin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-733	simvastatin	simvastatin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-733	simvastatin	simvastatin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43353-664	simvastatin	simvastatin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-664	simvastatin	simvastatin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-0999	simvastatin	simvastatin	A-S Medication Solutions	ANDA	Current
50090-0999	simvastatin	simvastatin	A-S Medication Solutions	ANDA	Current
50090-0999	simvastatin	simvastatin	A-S Medication Solutions	ANDA	Current
50090-0999	simvastatin	simvastatin	A-S Medication Solutions	ANDA	Current
50090-1000	simvastatin	simvastatin	A-S Medication Solutions	ANDA	Current

Documents

Document	Submission type	Date
23897	ORIG	2008-02-28