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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202294
Company: PAR PHARM INC
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
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-Patient Package Insert, Labeling-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-Package Insert, Labeling-Medication Guide

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.

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

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 202294 PAR PHARM INC

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 202294 PAR PHARM INC
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