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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202294
Company: PAR PHARM INC

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
08/03/2022	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/16/2022	SUPPL-6	Labeling-Container/Carton Labels, Labeling-Package Insert, 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	205205	MYLAN
DEXLANSOPRAZOLE	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	202294	PAR PHARM INC
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	205205	MYLAN
DEXLANSOPRAZOLE	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	202294	PAR PHARM INC
DEXLANSOPRAZOLE	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	202666	TWI PHARMS

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