U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 200411
Company: IMPAX LABS INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MORPHINE SULFATE MORPHINE SULFATE 20MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
MORPHINE SULFATE MORPHINE SULFATE 30MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
MORPHINE SULFATE MORPHINE SULFATE 50MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
MORPHINE SULFATE MORPHINE SULFATE 60MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
MORPHINE SULFATE MORPHINE SULFATE 80MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
MORPHINE SULFATE MORPHINE SULFATE 100MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
MORPHINE SULFATE MORPHINE SULFATE 40MG CAPSULE, EXTENDED RELEASE;ORAL 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
04/12/2016 ORIG-1 Approval Not Applicable

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/15/2023 SUPPL-23 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
12/15/2023 SUPPL-22 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
12/06/2023 SUPPL-21 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.
12/06/2023 SUPPL-20 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
12/06/2023 SUPPL-18 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
12/06/2023 SUPPL-14 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
09/18/2018 SUPPL-10 REMS - MODIFIED - D-N-A

Label is not available on this site.
05/26/2017 SUPPL-6 REMS-Modified

Label is not available on this site.
07/19/2018 SUPPL-5 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
05/19/2017 SUPPL-4 Labeling-Package Insert

Label is not available on this site.
09/30/2016 SUPPL-3 REMS - MODIFIED - D-N-A

Label is not available on this site.
04/20/2016 SUPPL-1 REMS-Modified

Label is not available on this site.
Back to Top