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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209655
Company: ZYDUS PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FENTANYL-100 FENTANYL 100MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None No No
FENTANYL-12 FENTANYL 12.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None No No
FENTANYL-25 FENTANYL 25MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None No No
FENTANYL-37 FENTANYL 37.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None No No
FENTANYL-50 FENTANYL 50MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None No No
FENTANYL-62 FENTANYL 62.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None No No
FENTANYL-75 FENTANYL 75MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None No No
FENTANYL-87 FENTANYL 87.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None 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
01/24/2023 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
12/22/2025 SUPPL-5 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
10/31/2024 SUPPL-3 REMS - MODIFIED - D-N-A

Label is not available on this site.
12/15/2023 SUPPL-2 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
12/15/2023 SUPPL-1 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.
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