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U.S. Department of Health and Human Services

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Search results from the "OB_Rx" table for query on "200533."



Active Ingredient: TAPENTADOL HYDROCHLORIDE
Dosage Form;Route: TABLET, EXTENDED RELEASE;ORAL
Proprietary Name: NUCYNTA ER
Applicant: JANSSEN PHARMS
Strength: EQ 50MG BASE
Application Number: N200533
Product Number: 001
Approval Date: Aug 25, 2011
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: TAPENTADOL HYDROCHLORIDE
Dosage Form;Route: TABLET, EXTENDED RELEASE;ORAL
Proprietary Name: NUCYNTA ER
Applicant: JANSSEN PHARMS
Strength: EQ 100MG BASE
Application Number: N200533
Product Number: 002
Approval Date: Aug 25, 2011
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: TAPENTADOL HYDROCHLORIDE
Dosage Form;Route: TABLET, EXTENDED RELEASE;ORAL
Proprietary Name: NUCYNTA ER
Applicant: JANSSEN PHARMS
Strength: EQ 150MG BASE
Application Number: N200533
Product Number: 003
Approval Date: Aug 25, 2011
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: TAPENTADOL HYDROCHLORIDE
Dosage Form;Route: TABLET, EXTENDED RELEASE;ORAL
Proprietary Name: NUCYNTA ER
Applicant: JANSSEN PHARMS
Strength: EQ 200MG BASE
Application Number: N200533
Product Number: 004
Approval Date: Aug 25, 2011
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: TAPENTADOL HYDROCHLORIDE
Dosage Form;Route: TABLET, EXTENDED RELEASE;ORAL
Proprietary Name: NUCYNTA ER
Applicant: JANSSEN PHARMS
Strength: EQ 250MG BASE
Application Number: N200533
Product Number: 005
Approval Date: Aug 25, 2011
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

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FDA/Center for Drug Evaluation and Research
Office of Generic Drugs
Division of Labeling and Program Support
Update Frequency:

Orange Book Data - Monthly
Generic Drug Product Information & Patent Information - Daily
Orange Book Data Updated Through September 2014
Patent and Generic Drug Product Data Last Updated October 21, 2014

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