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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 "078573."



Active Ingredient: AMLODIPINE BESYLATE
Dosage Form;Route: TABLET;ORAL
Proprietary Name: AMLODIPINE BESYLATE
Applicant: TORRENT PHARMS
Strength: EQ 2.5MG BASE
Application Number: A078573
Product Number: 001
Approval Date: Sep 22, 2008
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: AMLODIPINE BESYLATE
Dosage Form;Route: TABLET;ORAL
Proprietary Name: AMLODIPINE BESYLATE
Applicant: TORRENT PHARMS
Strength: EQ 5MG BASE
Application Number: A078573
Product Number: 002
Approval Date: Sep 22, 2008
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: AMLODIPINE BESYLATE
Dosage Form;Route: TABLET;ORAL
Proprietary Name: AMLODIPINE BESYLATE
Applicant: TORRENT PHARMS
Strength: EQ 10MG BASE
Application Number: A078573
Product Number: 003
Approval Date: Sep 22, 2008
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
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 May 2016
Patent and Generic Drug Product Data Last Updated June 28, 2016

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