Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074862
Company: RHODES PHARMS

• REMS

Products on ANDA 074862

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
MORPHINE SULFATE	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074862

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/07/1998	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74862ap_appltr_prntlbl_chemr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74862ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74862.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/18/2018	SUPPL-28	REMS - MODIFIED - D-N-A		Label is not available on this site.
05/26/2017	SUPPL-27	REMS-Modified		Label is not available on this site.
09/30/2016	SUPPL-26	REMS - MODIFIED - D-N-A		Label is not available on this site.
04/20/2016	SUPPL-23	REMS-Modified		Label is not available on this site.
06/26/2015	SUPPL-22	REMS-Proposal		Label is not available on this site.
08/19/2014	SUPPL-20	REMS-Modified		Label is not available on this site.
07/21/2014	SUPPL-19	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
04/15/2013	SUPPL-13	REMS-Modified		Label is not available on this site.
09/28/2012	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
07/09/2012	SUPPL-10	REMS-Proposal		Label is not available on this site.
07/11/2000	SUPPL-7	Manufacturing (CMC)-Facility		Label is not available on this site.
07/11/2000	SUPPL-6	Manufacturing (CMC)-Facility		Label is not available on this site.
07/11/2000	SUPPL-5	Manufacturing (CMC)-Facility		Label is not available on this site.
07/11/2000	SUPPL-4	Manufacturing (CMC)-Facility		Label is not available on this site.
07/11/2000	SUPPL-3	Manufacturing (CMC)-Facility		Label is not available on this site.
07/11/2000	SUPPL-2	Manufacturing (CMC)-Facility		Label is not available on this site.

Labels for ANDA 074862

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/07/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74862ap_appltr_prntlbl_chemr.pdf

Therapeutic Equivalents for ANDA 074862

MORPHINE SULFATE

TABLET, EXTENDED RELEASE;ORAL; 15MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203849	ACTAVIS ELIZABETH
MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	075407	DAVA PHARMS INC
MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203602	NOVEL LABS INC
MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	074862	RHODES PHARMS
MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	076412	SPECGX LLC
MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	075295	STRIDES PHARMA
MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	078761	SUN PHARM INDS LTD
MS CONTIN	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	019516	PURDUE PHARMA LP

TABLET, EXTENDED RELEASE;ORAL; 30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203849	ACTAVIS ELIZABETH
MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203602	NOVEL LABS INC
MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	074862	RHODES PHARMS
MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	076412	SPECGX LLC
MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	075295	STRIDES PHARMA
MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	078761	SUN PHARM INDS LTD
MS CONTIN	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	019516	PURDUE PHARMA LP

TABLET, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MORPHINE SULFATE	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203849	ACTAVIS ELIZABETH
MORPHINE SULFATE	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203602	NOVEL LABS INC
MORPHINE SULFATE	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	074862	RHODES PHARMS
MORPHINE SULFATE	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	076412	SPECGX LLC
MORPHINE SULFATE	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	075295	STRIDES PHARMA
MORPHINE SULFATE	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	078761	SUN PHARM INDS LTD
MS CONTIN	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	019516	PURDUE PHARMA LP