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FDA Drug Approval, A205954, BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
FDA Drug Approval, A205954, BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
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ANDA: 205954
Company: ALVOGEN
Drug Name: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Active Ingredients: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Strength: EQ 12MG BASE;EQ 3MG BASE
Dosage Form/Route: FILM;BUCCAL, SUBLINGUAL
Action Date: 01/24/2019
Marketing Status: Prescription
Submission Classification: ORIG-1 TE Code: AB
Company: ALVOGEN
Drug Name: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Active Ingredients: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Strength: EQ 12MG BASE;EQ 3MG BASE
Dosage Form/Route: FILM;BUCCAL, SUBLINGUAL
Action Date: 01/24/2019
Marketing Status: Prescription
Submission Classification: ORIG-1 TE Code: AB
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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