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): 200812
Company: STRIDES PHARMA INTL

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

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/10/2011 ORIG-1 Approval Not Applicable Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/200812Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/22/2025 SUPPL-17 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
10/31/2024 SUPPL-16 REMS - MODIFIED - D-N-A

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

Label is not available on this site.
12/01/2023 SUPPL-14 Labeling-Patient Package Insert, Labeling-Medication Guide

Label is not available on this site.
09/18/2018 SUPPL-13 REMS - MODIFIED - D-N-A

Label is not available on this site.
12/01/2023 SUPPL-12 Labeling-Package Insert

Label is not available on this site.
05/26/2017 SUPPL-11 REMS-Modified

Label is not available on this site.
09/30/2016 SUPPL-10 REMS - MODIFIED - D-N-A

Label is not available on this site.
04/20/2016 SUPPL-8 REMS-Modified

Label is not available on this site.
06/26/2015 SUPPL-6 REMS-Modified

Label is not available on this site.
08/19/2014 SUPPL-5 REMS-Modified

Label is not available on this site.
02/06/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.
04/24/2013 SUPPL-2 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
Back to Top