Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 205299

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BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE)
EQ 2MG BASE;EQ 0.5MG BASE
Marketing Status: Prescription

Active Ingredient: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Proprietary Name: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Dosage Form; Route of Administration: FILM; BUCCAL, SUBLINGUAL
Strength: EQ 2MG BASE;EQ 0.5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205299
Product Number: 001
Approval Date: Jun 14, 2018
Applicant Holder Full Name: DR REDDYS LABORATORIES SA
Marketing Status:  Prescription
Patent and Exclusivity Information

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE)
EQ 8MG BASE;EQ 2MG BASE
Marketing Status: Prescription

Active Ingredient: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Proprietary Name: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Dosage Form; Route of Administration: FILM; BUCCAL, SUBLINGUAL
Strength: EQ 8MG BASE;EQ 2MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205299
Product Number: 002
Approval Date: Jun 14, 2018
Applicant Holder Full Name: DR REDDYS LABORATORIES SA
Marketing Status:  Prescription
Patent and Exclusivity Information