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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
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Colorcon
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Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203874

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NDA 203874 describes AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM, which is a drug marketed by Dr Reddys Labs Ltd and Mylan Pharms Inc and is included in two NDAs. It is available from two suppliers. Additional details are available on the AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM profile page.

The generic ingredient in AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM is amlodipine besylate; atorvastatin calcium. There are fifty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the amlodipine besylate; atorvastatin calcium profile page.
Summary for 203874
Pharmacology for NDA: 203874
Suppliers and Packaging for NDA: 203874
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate; atorvastatin calcium TABLET;ORAL 203874 ANDA Dr. Reddy's Laboratories Inc 43598-313 N 43598-313-90
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate; atorvastatin calcium TABLET;ORAL 203874 ANDA Dr. Reddy's Laboratories Inc 43598-313 N 43598-313-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE;EQ 10MG BASE
Approval Date:Mar 7, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE;EQ 20MG BASE
Approval Date:Mar 7, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE;EQ 40MG BASE
Approval Date:Mar 7, 2014TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
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Dow
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Chinese Patent Office

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