Application 091134

Type: ANDA
Sponsor: ZYDUS PHARMS

Related Records

Company: ZYDUS PHARMS

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ETODOLAC	ETODOLAC	TABLET, EXTENDED RELEASE;ORAL	400MG	No	No
002	ETODOLAC	ETODOLAC	TABLET, EXTENDED RELEASE;ORAL	500MG	No	No
003	ETODOLAC	ETODOLAC	TABLET, EXTENDED RELEASE;ORAL	600MG	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-1317	Etodolac	Etodolac	A-S Medication Solutions	ANDA	Current
52959-649	Etodolac	Etodolac	H.J. HARKINS COMPANY, INC.	ANDA	Current
55700-601	Etodolac	Etodolac	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
60760-281	Etodolac	Etodolac	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-298	Etodolac	Etodolac	St. Mary's Medical Park Pharmacy	ANDA	Current
63187-374	Etodolac	Etodolac	Proficient Rx LP	ANDA	Current
63187-374	Etodolac	Etodolac	Proficient Rx LP	ANDA	Current
63629-8598	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current
63629-8598	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current
65841-777	Etodolac	Etodolac	Cadila Healthcare Limited	ANDA	Current
65841-777	Etodolac	Etodolac	Cadila Healthcare Limited	ANDA	Current
65841-777	Etodolac	Etodolac	Cadila Healthcare Limited	ANDA	Current
65841-777	Etodolac	Etodolac	Zydus Lifesciences Limited	ANDA	Current
65841-778	Etodolac	Etodolac	Zydus Lifesciences Limited	ANDA	Current
65841-778	Etodolac	Etodolac	Cadila Healthcare Limited	ANDA	Current
65841-778	Etodolac	Etodolac	Cadila Healthcare Limited	ANDA	Current
65841-778	Etodolac	Etodolac	Cadila Healthcare Limited	ANDA	Current
65841-779	Etodolac	Etodolac	Zydus Lifesciences Limited	ANDA	Current
65841-779	Etodolac	Etodolac	Cadila Healthcare Limited	ANDA	Current
65841-779	Etodolac	Etodolac	Cadila Healthcare Limited	ANDA	Current
65841-779	Etodolac	Etodolac	Cadila Healthcare Limited	ANDA	Current
68382-271	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-271	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-271	Etodolac	Etodolac	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-271	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-271	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-271	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-271	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-272	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-272	Etodolac	Etodolac	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-272	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-272	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-272	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-272	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-272	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-273	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-273	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-273	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-273	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-273	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-273	Etodolac	Etodolac	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-273	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70332-320	Etodolac	Etodolac	California Pharmaceuticals, LLC	ANDA	Current
71335-0183	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current