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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219115
Company: ALEMBIC

Products on ANDA 219115

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXLANSOPRAZOLE	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	AB	No	No
DEXLANSOPRAZOLE	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219115

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/12/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219115

DEXLANSOPRAZOLE

CAPSULE, DELAYED RELEASE;ORAL; 30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEXILANT	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	Yes	AB	022287	TAKEDA PHARMS USA
DEXLANSOPRAZOLE	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	219115	ALEMBIC
DEXLANSOPRAZOLE	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	205205	MYLAN
DEXLANSOPRAZOLE	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	202294	PH HEALTH
DEXLANSOPRAZOLE	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	202666	TWI PHARMS

CAPSULE, DELAYED RELEASE;ORAL; 60MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEXILANT	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	Yes	AB	022287	TAKEDA PHARMS USA
DEXLANSOPRAZOLE	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	219115	ALEMBIC
DEXLANSOPRAZOLE	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	205205	MYLAN
DEXLANSOPRAZOLE	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	202294	PH HEALTH
DEXLANSOPRAZOLE	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	202666	TWI PHARMS

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