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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091134
Company: ZYDUS PHARMS

Products on ANDA 091134

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ETODOLAC	ETODOLAC	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
ETODOLAC	ETODOLAC	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
ETODOLAC	ETODOLAC	600MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091134

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/23/2014	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2021	SUPPL-8	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/26/2021	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/09/2016	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091134

ETODOLAC

TABLET, EXTENDED RELEASE;ORAL; 400MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ETODOLAC	ETODOLAC	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	212263	BAYSHORE PHARMS LLC
ETODOLAC	ETODOLAC	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	076174	TARO
ETODOLAC	ETODOLAC	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	075665	TEVA
ETODOLAC	ETODOLAC	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	091134	ZYDUS PHARMS

TABLET, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ETODOLAC	ETODOLAC	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	212263	BAYSHORE PHARMS LLC
ETODOLAC	ETODOLAC	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	076174	TARO
ETODOLAC	ETODOLAC	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	075665	TEVA
ETODOLAC	ETODOLAC	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	091134	ZYDUS PHARMS

TABLET, EXTENDED RELEASE;ORAL; 600MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ETODOLAC	ETODOLAC	600MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	212263	BAYSHORE PHARMS LLC
ETODOLAC	ETODOLAC	600MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	076174	TARO
ETODOLAC	ETODOLAC	600MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	075665	TEVA
ETODOLAC	ETODOLAC	600MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	091134	ZYDUS PHARMS

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