Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208653

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APADAZ (ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE)
325MG;EQ 4.08MG BASE
Marketing Status: Prescription
Active Ingredient: ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE
Proprietary Name: APADAZ
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;EQ 4.08MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208653
Product Number: 002
Approval Date: Jan 4, 2019
Applicant Holder Full Name: KVK TECH INC
Marketing Status:  Prescription
Patent and Exclusivity Information
APADAZ (ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE)
325MG;EQ 6.12MG BASE
Marketing Status: Prescription
Active Ingredient: ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE
Proprietary Name: APADAZ
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;EQ 6.12MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208653
Product Number: 001
Approval Date: Feb 23, 2018
Applicant Holder Full Name: KVK TECH INC
Marketing Status:  Prescription
Patent and Exclusivity Information
APADAZ (ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE)
325MG;EQ 8.16MG BASE
Marketing Status: Prescription
Active Ingredient: ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE
Proprietary Name: APADAZ
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;EQ 8.16MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208653
Product Number: 003
Approval Date: Jan 4, 2019
Applicant Holder Full Name: KVK TECH INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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