Application 208174

Type: ANDA
Sponsor: TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RANOLAZINE	RANOLAZINE	TABLET, EXTENDED RELEASE;ORAL	500MG	No	No
002	RANOLAZINE	RANOLAZINE	TABLET, EXTENDED RELEASE;ORAL	1000MG	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 2 of 2 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RANOLAZINE	RANOLAZINE	ScieGen Pharmaceuticals, Inc	71d50258-75b7-4801-b0f4-c34fe883d57d	2024-12-24	Warnings, Adverse reactions	Name fallback brand name: RANOLAZINE generic name: RANOLAZINE
Ranolazine	RANOLAZINE	Proficient Rx LP	c7ed8234-e6bd-4f19-a1ce-40f272a79036	2024-07-01	Warnings, Adverse reactions	Name fallback brand name: Ranolazine generic name: RANOLAZINE
Ranolazine	RANOLAZINE	Aphena Pharma Solutions - Tennessee, LLC	abb32182-46ba-49d2-b2ac-13de2ecf802d	2024-04-02	Warnings, Adverse reactions	Name fallback brand name: Ranolazine generic name: RANOLAZINE
Ranolazine	RANOLAZINE	Aurobindo Pharma Limited	49873158-5c0a-41da-86a2-369ef6b0cbc8	2024-02-15	Warnings, Adverse reactions	Name fallback brand name: Ranolazine generic name: RANOLAZINE
RANOLAZINE	RANOLAZINE	Lupin Pharmaceuticals, Inc.	595821d7-1fbf-49a5-9c62-d78f27af39b4	2023-12-08	Warnings, Adverse reactions	Name fallback brand name: RANOLAZINE generic name: RANOLAZINE
Ranolazine	RANOLAZINE	Unichem Pharmaceuticals (USA), Inc.	e2a8c9f9-5f6a-4496-8fd6-2439e564db4f	2023-11-06	Warnings, Adverse reactions	Name fallback brand name: Ranolazine generic name: RANOLAZINE
Ranolazine	RANOLAZINE	Camber Pharmaceuticals, Inc.	82948cdb-73af-4f3f-bd03-628ed0fdbfba	2022-05-13	Warnings, Adverse reactions	Name fallback brand name: Ranolazine generic name: RANOLAZINE
RANOLAZINE	RANOLAZINE	i3 Pharmaceuticals, LLC	de3185bf-448a-15f7-e053-2995a90a9a2e	2022-05-04	Warnings, Adverse reactions	Name fallback brand name: RANOLAZINE generic name: RANOLAZINE
Ranolazine	RANOLAZINE	Proficient Rx LP	989e1688-a0b5-4297-bf91-234de2a0b445	2022-03-01	Warnings, Adverse reactions	Name fallback brand name: Ranolazine generic name: RANOLAZINE
Ranolazine	RANOLAZINE	Westminster Pharmaceuticals, LLC	b91e88a0-04d0-4d0d-92d8-966b27a48e29	2021-09-02	Warnings, Adverse reactions	Name fallback brand name: Ranolazine generic name: RANOLAZINE
Ranolazine	RANOLAZINE	Sun Pharmaceutical Industries, Inc.	c5848232-b7fd-4fe5-a543-16d6c4b5c0b1	2020-08-17	Warnings, Adverse reactions	Name fallback brand name: Ranolazine generic name: RANOLAZINE

Reported adverse events (FAERS/openFDA)#

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