Application Nr Approved Date Route Status External Links
ANDA074862 1998-07-07 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Morphine Sulfate Extended-Release Tablets Are An Extended-Release Oral Formulation Of Morphine Sulfate Indicated For The Management Of Moderate To Severe Pain When A Continuous, Around-The-Clock Opioid Analgesic Is Needed For An Extended Period Of Time. Morphine Sulfate Extended-Release Tablets Are Not Intended For Use As A Prn Analgesic. The Morphine Sulfate Extended-Release Tablets 100 And 200 Mg Tablet Strengths Are High Dose, Extended-Release, Oral Morphine Formulations Indicated For The Relief Of Pain In Opioid-Tolerant Patients Only. Morphine Sulfate Extended-Release Tablets Are Not Indicated For Pain In The Immediate Postoperative Period (the First 12-24 Hours Following Surgery) For Patients Not Previously Taking The Drug, Because Its Safety In This Setting Has Not Been Established. Morphine Sulfate Extended-Release Tablets Are Not Indicated For Pain In The Postoperative Period If The Pain Is Mild, Or Not Expected To Persist For An Extended Period Of Time. Morphine Sulfate Extended-Release Tablets Are Only Indicated For Postoperative Use If The Patient Is Already Receiving The Drug Prior To Surgery Or If The Postoperative Pain Is Expected To Be Moderate To Severe And Persist For An Extended Period Of Time. Physicians Should Individualize Treatment, Moving From Parenteral To Oral Analgesics As Appropriate. (see American Pain Society Guidelines.)

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Cetostearyl Alcohol CETOSTEARYL ALCOHOL Unresolved
2. Hydroxyethyl Cellulose HYDROXYETHYL CELLULOSE Unresolved
3. Hypromelloses HYPROMELLOSES Unresolved
4. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
5. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Morphine Sulfate MORPHINE SULFATE ZINC3812983

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