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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 205977


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NDA 205977 describes PITAVASTATIN CALCIUM, which is a drug marketed by Amneal Pharms Ny, Aurobindo Pharma, Hetero Labs Ltd V, Lupin Ltd, Mylan, Orient Pharma Co Ltd, Sawai Usa, and Zydus Pharms, and is included in eight NDAs. It is available from nine suppliers. Additional details are available on the PITAVASTATIN CALCIUM profile page.

The generic ingredient in PITAVASTATIN CALCIUM is pitavastatin calcium. There are fifteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the pitavastatin calcium profile page.
Summary for 205977
Tradename:PITAVASTATIN CALCIUM
Applicant:Hetero Labs Ltd V
Ingredient:pitavastatin calcium
Patents:0
Pharmacology for NDA: 205977
Suppliers and Packaging for NDA: 205977
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PITAVASTATIN CALCIUM pitavastatin calcium TABLET;ORAL 205977 ANDA Camber Pharmaceuticals, Inc. 31722-875 31722-875-90 90 TABLET, FILM COATED in 1 BOTTLE (31722-875-90)
PITAVASTATIN CALCIUM pitavastatin calcium TABLET;ORAL 205977 ANDA Camber Pharmaceuticals, Inc. 31722-876 31722-876-90 90 TABLET, FILM COATED in 1 BOTTLE (31722-876-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Apr 30, 2024TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2MG BASE
Approval Date:Apr 30, 2024TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:Apr 30, 2024TE:ABRLD:No

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