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Details for New Drug Application (NDA): 091624

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NDA 091624 describes ATORVASTATIN CALCIUM, which is a drug marketed by Sciegen Pharms Inc, Kremers Urban Pharms, Mylan Pharms Inc, Apotex Inc, Dr Reddys Labs Ltd, Teva Pharms, Sandoz Inc, and Sun Pharm Inds Ltd, and is included in nine NDAs. It is available from forty-five suppliers. Additional details are available on the ATORVASTATIN CALCIUM profile page.

The generic ingredient in ATORVASTATIN CALCIUM is atorvastatin calcium. There are sixty drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the atorvastatin calcium profile page.

Summary for NDA: 091624

Tradename:
ATORVASTATIN CALCIUM
Applicant:
Kremers Urban Pharms
Ingredient:
atorvastatin calcium
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 091624

Suppliers and Packaging for NDA: 091624

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATORVASTATIN CALCIUM
atorvastatin calcium
TABLET;ORAL 091624 ANDA AvKARE, Inc. 42291-143 42291-143-10 1000 TABLET, FILM COATED in 1 BOTTLE (42291-143-10)
ATORVASTATIN CALCIUM
atorvastatin calcium
TABLET;ORAL 091624 ANDA AvKARE, Inc. 42291-143 42291-143-90 90 TABLET, FILM COATED in 1 BOTTLE (42291-143-90)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Apr 5, 2013TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Apr 5, 2013TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 40MG BASE
Approval Date:Apr 5, 2013TE:ABRLD:No


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