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Generated: June 17, 2019

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Details for New Drug Application (NDA): 200465

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NDA 200465 describes AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM, which is a drug marketed by Dr Reddys Labs Ltd, Mylan Pharms Inc, and Zydus Pharms Usa Inc, and is included in three NDAs. It is available from four 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. Six suppliers are listed for this compound. Additional details are available on the amlodipine besylate; atorvastatin calcium profile page.
Suppliers and Packaging for NDA: 200465
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 200465 ANDA Mylan Pharmaceuticals Inc. 0378-4510 0378-4510-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4510-93)
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate; atorvastatin calcium TABLET;ORAL 200465 ANDA Mylan Pharmaceuticals Inc. 0378-4511 0378-4511-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4511-93)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE;EQ 10MG BASE
Approval Date:Nov 29, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE;EQ 20MG BASE
Approval Date:Nov 29, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE;EQ 40MG BASE
Approval Date:Nov 29, 2013TE:ABRLD:No

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