An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 202294
Company: PH HEALTH

Products on ANDA 202294

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202294

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/19/2017	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202294Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202294Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/14/2025	SUPPL-16	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/14/2025	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
08/03/2022	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/16/2022	SUPPL-6	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert		Label is not available on this site.
05/03/2022	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/03/2022	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/01/2020	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 202294

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/19/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202294Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 202294

DEXLANSOPRAZOLE

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

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

Top