Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205448
Company: IPCA LABS LTD

Products on ANDA 205448

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ETODOLAC	ETODOLAC	200MG	CAPSULE;ORAL	Prescription	AB	No	No
ETODOLAC	ETODOLAC	300MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205448

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/01/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/22/2024	SUPPL-2	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/21/2024	SUPPL-1	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 205448

ETODOLAC

CAPSULE;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ETODOLAC	ETODOLAC	200MG	CAPSULE;ORAL	Prescription	No	AB	075126	ANI PHARMS
ETODOLAC	ETODOLAC	200MG	CAPSULE;ORAL	Prescription	No	AB	075419	APOTEX
ETODOLAC	ETODOLAC	200MG	CAPSULE;ORAL	Prescription	No	AB	205448	IPCA LABS LTD
ETODOLAC	ETODOLAC	200MG	CAPSULE;ORAL	Prescription	No	AB	075078	TARO

CAPSULE;ORAL; 300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ETODOLAC	ETODOLAC	300MG	CAPSULE;ORAL	Prescription	No	AB	075126	ANI PHARMS
ETODOLAC	ETODOLAC	300MG	CAPSULE;ORAL	Prescription	No	AB	075419	APOTEX
ETODOLAC	ETODOLAC	300MG	CAPSULE;ORAL	Prescription	No	AB	205448	IPCA LABS LTD
ETODOLAC	ETODOLAC	300MG	CAPSULE;ORAL	Prescription	No	AB	075078	TARO