Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 206029

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PITAVASTATIN CALCIUM (PITAVASTATIN CALCIUM)
EQ 1MG BASE
Marketing Status: Prescription

Active Ingredient: PITAVASTATIN CALCIUM
Proprietary Name: PITAVASTATIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 1MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206029
Product Number: 001
Approval Date: Nov 20, 2023
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

PITAVASTATIN CALCIUM (PITAVASTATIN CALCIUM)
EQ 2MG BASE
Marketing Status: Prescription

Active Ingredient: PITAVASTATIN CALCIUM
Proprietary Name: PITAVASTATIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 2MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206029
Product Number: 002
Approval Date: Nov 20, 2023
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

PITAVASTATIN CALCIUM (PITAVASTATIN CALCIUM)
EQ 4MG BASE
Marketing Status: Prescription

Active Ingredient: PITAVASTATIN CALCIUM
Proprietary Name: PITAVASTATIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 4MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206029
Product Number: 003
Approval Date: Nov 20, 2023
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Prescription
Patent and Exclusivity Information