Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 208269

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HYDROCODONE BITARTRATE (HYDROCODONE BITARTRATE)
20MG
Marketing Status: Prescription

Active Ingredient: HYDROCODONE BITARTRATE
Proprietary Name: HYDROCODONE BITARTRATE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208269
Product Number: 001
Approval Date: Mar 1, 2021
Applicant Holder Full Name: ALVOGEN INC
Marketing Status:  Prescription
Patent and Exclusivity Information

HYDROCODONE BITARTRATE (HYDROCODONE BITARTRATE)
30MG
Marketing Status: Prescription

Active Ingredient: HYDROCODONE BITARTRATE
Proprietary Name: HYDROCODONE BITARTRATE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208269
Product Number: 002
Approval Date: Mar 1, 2021
Applicant Holder Full Name: ALVOGEN INC
Marketing Status:  Prescription
Patent and Exclusivity Information

HYDROCODONE BITARTRATE (HYDROCODONE BITARTRATE)
40MG
Marketing Status: Prescription

Active Ingredient: HYDROCODONE BITARTRATE
Proprietary Name: HYDROCODONE BITARTRATE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208269
Product Number: 003
Approval Date: Mar 1, 2021
Applicant Holder Full Name: ALVOGEN INC
Marketing Status:  Prescription
Patent and Exclusivity Information

HYDROCODONE BITARTRATE (HYDROCODONE BITARTRATE)
60MG
Marketing Status: Prescription

Active Ingredient: HYDROCODONE BITARTRATE
Proprietary Name: HYDROCODONE BITARTRATE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 60MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208269
Product Number: 004
Approval Date: Mar 1, 2021
Applicant Holder Full Name: ALVOGEN INC
Marketing Status:  Prescription
Patent and Exclusivity Information

HYDROCODONE BITARTRATE (HYDROCODONE BITARTRATE)
80MG
Marketing Status: Prescription

Active Ingredient: HYDROCODONE BITARTRATE
Proprietary Name: HYDROCODONE BITARTRATE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 80MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208269
Product Number: 005
Approval Date: Mar 1, 2021
Applicant Holder Full Name: ALVOGEN INC
Marketing Status:  Prescription
Patent and Exclusivity Information

HYDROCODONE BITARTRATE (HYDROCODONE BITARTRATE)
100MG
Marketing Status: Prescription

Active Ingredient: HYDROCODONE BITARTRATE
Proprietary Name: HYDROCODONE BITARTRATE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208269
Product Number: 006
Approval Date: Mar 1, 2021
Applicant Holder Full Name: ALVOGEN INC
Marketing Status:  Prescription
Patent and Exclusivity Information

HYDROCODONE BITARTRATE (HYDROCODONE BITARTRATE)
120MG
Marketing Status: Prescription

Active Ingredient: HYDROCODONE BITARTRATE
Proprietary Name: HYDROCODONE BITARTRATE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 120MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208269
Product Number: 007
Approval Date: Mar 1, 2021
Applicant Holder Full Name: ALVOGEN INC
Marketing Status:  Prescription
Patent and Exclusivity Information