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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 Mylan Pharms Inc and Dr Reddys Labs Ltd 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 forty-nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the amlodipine besylate; atorvastatin calcium profile page.

Summary for NDA: 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 43598-313-05 500 TABLET, FILM COATED in 1 BOTTLE (43598-313-05)
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
amlodipine besylate; atorvastatin calcium
TABLET;ORAL 203874 ANDA Dr. Reddy's Laboratories Inc 43598-313 43598-313-30 30 TABLET, FILM COATED in 1 BOTTLE (43598-313-30)

Summary for product number 001

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

Summary for product number 002

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

Summary 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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