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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076438
Company: SPECGX LLC

REMS

Products on ANDA 076438

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MORPHINE SULFATE	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
MORPHINE SULFATE	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076438

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/03/2003	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/18/2018	SUPPL-25	REMS - MODIFIED - D-N-A		Label is not available on this site.
05/26/2017	SUPPL-23	REMS-Modified		Label is not available on this site.
09/30/2016	SUPPL-22	REMS - MODIFIED - D-N-A		Label is not available on this site.
11/03/2016	SUPPL-21	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/20/2016	SUPPL-19	REMS-Modified		Label is not available on this site.
06/26/2015	SUPPL-17	REMS-Modified		Label is not available on this site.
05/16/2015	SUPPL-16	Labeling-Container/Carton Labels		Label is not available on this site.
08/19/2014	SUPPL-15	REMS-Modified		Label is not available on this site.
06/25/2014	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/15/2013	SUPPL-12	REMS-Modified		Label is not available on this site.
07/09/2012	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
07/09/2012	SUPPL-10	REMS-Proposal		Label is not available on this site.
08/13/2014	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
07/22/2009	SUPPL-7	Labeling		Label is not available on this site.
09/30/2004	SUPPL-5	Labeling		Label is not available on this site.
11/06/2003	SUPPL-3	Labeling		Label is not available on this site.
03/19/2004	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076438

MORPHINE SULFATE

TABLET, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MORPHINE SULFATE	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203849	ACTAVIS ELIZABETH
MORPHINE SULFATE	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203602	NOVEL LABS INC
MORPHINE SULFATE	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	074769	RHODES PHARMS
MORPHINE SULFATE	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	076438	SPECGX LLC
MORPHINE SULFATE	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	075295	STRIDES PHARMA
MORPHINE SULFATE	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	078761	SUN PHARM INDS LTD
MS CONTIN	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	019516	PURDUE PHARMA LP

TABLET, EXTENDED RELEASE;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MORPHINE SULFATE	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203849	ACTAVIS ELIZABETH
MORPHINE SULFATE	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203602	NOVEL LABS INC
MORPHINE SULFATE	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	074769	RHODES PHARMS
MORPHINE SULFATE	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	076438	SPECGX LLC
MORPHINE SULFATE	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	075295	STRIDES PHARMA
MORPHINE SULFATE	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	078761	SUN PHARM INDS LTD
MS CONTIN	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	019516	PURDUE PHARMA LP

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