Drugs@FDA: FDA-Approved Drugs

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

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 205386 MAYNE PHARMA INC
MORPHINE SULFATE MORPHINE SULFATE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076733 NESHER PHARMS
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 078761 SUN PHARM INDS LTD
MORPHINE SULFATE MORPHINE SULFATE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075295 VINTAGE PHARMS LLC
MS CONTIN MORPHINE SULFATE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 019516 PURDUE PHARMA LP

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