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General MedicationsSUBLINGUALGeneric

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Standard Dose
EQ 1.4MG BASE;EQ 0.36MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary

Approval overview BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE is listed in Drugs@FDA under application 214737 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE Form and strength TABLET;SUBLINGUAL - EQ 1.4MG BASE;EQ 0.36MG BASE Sponsor SUN PHARM INDUSTRIES Submission history Latest submission status date: 2023-08-11 00:00:00.

Structured Monograph

Clinical summary

Approval overview BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE is listed in Drugs@FDA under application 214737 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE Form and strength TABLET;SUBLINGUAL - EQ 1.4MG BASE;EQ 0.36MG BASE Sponsor SUN PHARM INDUSTRIES Submission history Latest submission status date: 2023-08-11 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: None (Tentative Approval)
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.