Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075407
Company: DAVA PHARMS INC

Products on ANDA 075407

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075407

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/28/2000	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75407ltr.pdf

Therapeutic Equivalents for ANDA 075407

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