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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 091226

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ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
EQ 10MG BASE
Marketing Status: Prescription
Active Ingredient: ATORVASTATIN CALCIUM
Proprietary Name: ATORVASTATIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091226
Product Number: 001
Approval Date: May 29, 2012
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
EQ 20MG BASE
Marketing Status: Prescription
Active Ingredient: ATORVASTATIN CALCIUM
Proprietary Name: ATORVASTATIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091226
Product Number: 002
Approval Date: May 29, 2012
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
EQ 40MG BASE
Marketing Status: Prescription
Active Ingredient: ATORVASTATIN CALCIUM
Proprietary Name: ATORVASTATIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 40MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091226
Product Number: 003
Approval Date: May 29, 2012
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
EQ 80MG BASE
Marketing Status: Prescription
Active Ingredient: ATORVASTATIN CALCIUM
Proprietary Name: ATORVASTATIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 80MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091226
Product Number: 004
Approval Date: May 29, 2012
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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