An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 203849
Company: ACTAVIS ELIZABETH

REMS

Products on ANDA 203849

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
MORPHINE SULFATE	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
MORPHINE SULFATE	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
MORPHINE SULFATE	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203849

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/06/2015	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203849Orig1s000MG.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203849Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/18/2026	SUPPL-28	REMS - MODIFIED - D-N-A		Label is not available on this site.
10/31/2024	SUPPL-25	REMS - MODIFIED - D-N-A		Label is not available on this site.
09/18/2018	SUPPL-15	REMS - MODIFIED - D-N-A		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-7	REMS - MODIFIED - D-N-A		Label is not available on this site.
04/20/2016	SUPPL-4	REMS-Modified		Label is not available on this site.
06/26/2015	SUPPL-1	REMS-Modified		Label is not available on this site.

Labels for ANDA 203849

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/06/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203849Orig1s000MG.pdf

Top