Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079040
Company: ACTAVIS ELIZABETH

• REMS

Products on ANDA 079040

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MORPHINE SULFATE	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	No	No
MORPHINE SULFATE	MORPHINE SULFATE	45MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	No	No
MORPHINE SULFATE	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	No	No
MORPHINE SULFATE	MORPHINE SULFATE	75MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	No	No
MORPHINE SULFATE	MORPHINE SULFATE	90MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	No	No
MORPHINE SULFATE	MORPHINE SULFATE	120MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 079040

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/16/2013	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2013/079040Orig1s000Approv.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-27	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-26	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/04/2023	SUPPL-24	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/11/2019	SUPPL-21	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/02/2021	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-18	REMS - MODIFIED - D-N-A		Label is not available on this site.
05/26/2017	SUPPL-17	REMS-Modified		Label is not available on this site.
03/11/2021	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
09/30/2016	SUPPL-14	REMS - MODIFIED - D-N-A		Label is not available on this site.
03/11/2021	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
04/20/2016	SUPPL-11	REMS-Modified		Label is not available on this site.
06/26/2015	SUPPL-10	REMS-Modified		Label is not available on this site.
08/19/2014	SUPPL-7	REMS-Modified		Label is not available on this site.
07/03/2014	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
07/02/2014	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
04/15/2013	SUPPL-3	REMS-Modified		Label is not available on this site.