Application 076532

Type: ANDA
Sponsor: TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SIMVASTATIN	SIMVASTATIN	TABLET; ORAL	5MG	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	80MG	No	No

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SIMVASTATIN	SIMVASTATIN	NCS HealthCare of KY, LLC dba Vangard Labs	1ddc0230-24ab-4e69-9c6c-6776c354c82c	2024-09-13	Warnings, Adverse reactions	Name fallback brand name: SIMVASTATIN generic name: SIMVASTATIN
simvastatin	SIMVASTATIN	Bryant Ranch Prepack	b6d5fb21-a1a8-53e5-80d9-dde0eede5ef5	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: simvastatin generic name: SIMVASTATIN
simvastatin	SIMVASTATIN	Bryant Ranch Prepack	356ed6a6-e467-4791-87ff-2ae7779fc1b0	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: simvastatin generic name: SIMVASTATIN
simvastatin	SIMVASTATIN	Bryant Ranch Prepack	ce3ac5e8-bdef-d195-e0a0-e1a982008efe	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: simvastatin generic name: SIMVASTATIN
simvastatin	SIMVASTATIN	Bryant Ranch Prepack	79ca09cd-2396-4e50-b159-1f9567115067	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	Quallent Pharmaceuticals Health LLC	2b4255a7-f9f5-4235-8dbb-b0f03acbd624	2024-07-23	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	54c236ce-69c2-06ef-e054-00144ff88e88	2024-07-15	Warnings, Adverse reactions	Name fallback brand name: simvastatin generic name: SIMVASTATIN
simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	54c28733-eb99-10f6-e054-00144ff88e88	2024-07-10	Warnings, Adverse reactions	Name fallback brand name: simvastatin generic name: SIMVASTATIN
simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	8ed46bb1-9f84-4418-e053-2a95a90abd4b	2024-06-18	Warnings, Adverse reactions	Name fallback brand name: simvastatin generic name: SIMVASTATIN
simvastatin	SIMVASTATIN	NuCare Pharmaceuticals,Inc.	8e986df7-3020-6755-e053-2995a90aca37	2024-06-18	Warnings, Adverse reactions	Name fallback brand name: simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	Bryant Ranch Prepack	4277e75a-7f3b-4f35-ae56-0bbe095586a5	2024-05-22	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	Bryant Ranch Prepack	440dff4b-c377-48f3-bf24-07fd986b6fee	2024-05-22	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	NorthStar Rx LLC	0376351b-f1a0-43e5-a0b4-533072c49f39	2024-04-15	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	Camber Pharmaceuticals, Inc.	751b79c6-bba8-4d29-b69c-a2ac6453fec8	2024-04-05	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	A-S Medication Solutions	2e579278-c105-4cda-92ca-a3496d846c82	2024-02-15	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	A-S Medication Solutions	7fc4df06-48cb-481a-b7b2-d951def683ea	2023-12-25	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	Bryant Ranch Prepack	14bd8444-1556-4636-9e56-28da21a852fc	2023-10-30	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	Biocon Pharma Inc,	7b325108-6940-50a7-96b4-822a5206e568	2023-09-26	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
Simvastatin	SIMVASTATIN	A-S Medication Solutions	34c8c080-97b5-4580-b8fb-3fd557cdb40a	2023-05-03	Warnings, Adverse reactions	Name fallback brand name: Simvastatin generic name: SIMVASTATIN
SIMVASTATIN	SIMVASTATIN	Proficient Rx LP	dad0dd7d-3049-4be4-aaeb-8a1895d55208	2023-05-01	Warnings, Adverse reactions	Name fallback brand name: SIMVASTATIN generic name: SIMVASTATIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44310	ORIG	2011-05-26