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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 207975

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VANTRELA ER (HYDROCODONE BITARTRATE)
15MG
Marketing Status: Discontinued
Active Ingredient: HYDROCODONE BITARTRATE
Proprietary Name: VANTRELA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207975
Product Number: 001
Approval Date: Jan 17, 2017
Applicant Holder Full Name: TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
VANTRELA ER (HYDROCODONE BITARTRATE)
30MG
Marketing Status: Discontinued
Active Ingredient: HYDROCODONE BITARTRATE
Proprietary Name: VANTRELA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207975
Product Number: 002
Approval Date: Jan 17, 2017
Applicant Holder Full Name: TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
VANTRELA ER (HYDROCODONE BITARTRATE)
45MG
Marketing Status: Discontinued
Active Ingredient: HYDROCODONE BITARTRATE
Proprietary Name: VANTRELA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 45MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207975
Product Number: 003
Approval Date: Jan 17, 2017
Applicant Holder Full Name: TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
VANTRELA ER (HYDROCODONE BITARTRATE)
60MG
Marketing Status: Discontinued
Active Ingredient: HYDROCODONE BITARTRATE
Proprietary Name: VANTRELA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 60MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207975
Product Number: 004
Approval Date: Jan 17, 2017
Applicant Holder Full Name: TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
VANTRELA ER (HYDROCODONE BITARTRATE)
90MG
Marketing Status: Discontinued
Active Ingredient: HYDROCODONE BITARTRATE
Proprietary Name: VANTRELA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 90MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207975
Product Number: 005
Approval Date: Jan 17, 2017
Applicant Holder Full Name: TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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