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General MedicationsORALGeneric

EMBEDA

MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE

Standard Dose
100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview EMBEDA is listed in Drugs@FDA under application 022321 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE Form and strength CAPSULE, EXTENDED RELEASE;ORAL - 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ALPHARMA PHARMS Submission history Latest submission status date: 2019-10-07 00:00:00.

Structured Monograph

Clinical summary

Approval overview EMBEDA is listed in Drugs@FDA under application 022321 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE Form and strength CAPSULE, EXTENDED RELEASE;ORAL - 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ALPHARMA PHARMS Submission history Latest submission status date: 2019-10-07 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.