Application Nr Approved Date Route Status External Links
ANDA200812 2011-11-10 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Morphine Sulfate Extended-Release Capsules, Usp 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 (see Clinical Pharmacology ). Morphine Sulfate Extended-Release Capsules, Usp Are Not Intended For Use As A Prn Analgesic. Morphine Sulfate Extended-Release Capsules, Usp Are Not Indicated For Pain In The Immediate Postoperative Period (the First 12 To 24 Hours Following Surgery), Or If The Pain Is Mild Or Not Expected To Persist For An Extended Period Of Time. Morphine Sulfate Extended-Release Capsules, Usp 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. Diethyl Phthalate DIETHYL PHTHALATE Molecular
2. Ethylcelluloses ETHYLCELLULOSES Unresolved
3. Methacrylic Acid Copolymer METHACRYLIC ACID COPOLYMER Unresolved
4. Polyethylene Glycol 6000 POLYETHYLENE GLYCOL 6000 Unresolved
5. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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

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