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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 090622

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BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
EQ 2MG BASE
Marketing Status: Prescription
Active Ingredient: BUPRENORPHINE HYDROCHLORIDE
Proprietary Name: BUPRENORPHINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: EQ 2MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090622
Product Number: 001
Approval Date: Sep 24, 2010
Applicant Holder Full Name: ETHYPHARM
Marketing Status:  Prescription
Patent and Exclusivity Information
BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
EQ 8MG BASE
Marketing Status: Prescription
Active Ingredient: BUPRENORPHINE HYDROCHLORIDE
Proprietary Name: BUPRENORPHINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: EQ 8MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090622
Product Number: 002
Approval Date: Sep 24, 2010
Applicant Holder Full Name: ETHYPHARM
Marketing Status:  Prescription
Patent and Exclusivity Information
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