Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 211586

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BUPRENORPHINE (BUPRENORPHINE)
5MCG/HR
Marketing Status: Prescription

Active Ingredient: BUPRENORPHINE
Proprietary Name: BUPRENORPHINE
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 5MCG/HR
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211586
Product Number: 001
Approval Date: Apr 14, 2020
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

BUPRENORPHINE (BUPRENORPHINE)
7.5MCG/HR
Marketing Status: Prescription

Active Ingredient: BUPRENORPHINE
Proprietary Name: BUPRENORPHINE
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 7.5MCG/HR
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211586
Product Number: 002
Approval Date: Apr 14, 2020
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

BUPRENORPHINE (BUPRENORPHINE)
10MCG/HR
Marketing Status: Prescription

Active Ingredient: BUPRENORPHINE
Proprietary Name: BUPRENORPHINE
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 10MCG/HR
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211586
Product Number: 003
Approval Date: Apr 14, 2020
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

BUPRENORPHINE (BUPRENORPHINE)
15MCG/HR
Marketing Status: Prescription

Active Ingredient: BUPRENORPHINE
Proprietary Name: BUPRENORPHINE
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 15MCG/HR
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211586
Product Number: 004
Approval Date: Apr 14, 2020
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

BUPRENORPHINE (BUPRENORPHINE)
20MCG/HR
Marketing Status: Prescription

Active Ingredient: BUPRENORPHINE
Proprietary Name: BUPRENORPHINE
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 20MCG/HR
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211586
Product Number: 005
Approval Date: Apr 14, 2020
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information