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FDA Drug information

Pitavastatin calcium

Read time: 1 mins
Marketing start date: 05 May 2024
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Summary of product characteristics


Effective Time

20231103

Version

4

Spl Product Data Elements

pitavastatin calcium pitavastatin calcium PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM CARBONATE CROSPOVIDONE (120 .MU.M) HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE SODIUM CARBONATE POLYETHYLENE GLYCOL, UNSPECIFIED TALC TITANIUM DIOXIDE WHITE TO OFF-WHITE ROUND 481 pitavastatin calcium pitavastatin calcium PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM CARBONATE CROSPOVIDONE (120 .MU.M) HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE SODIUM CARBONATE POLYETHYLENE GLYCOL, UNSPECIFIED TALC TITANIUM DIOXIDE WHITE TO OFF-WHITE ROUND 482 pitavastatin calcium pitavastatin calcium PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM CARBONATE CROSPOVIDONE (120 .MU.M) HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE SODIUM CARBONATE POLYETHYLENE GLYCOL, UNSPECIFIED TALC TITANIUM DIOXIDE WHITE TO OFF-WHITE ROUND 483

Application Number

ANDA206047

Brand Name

Pitavastatin calcium

Generic Name

pitavastatin calcium

Product Ndc

70771-1784

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Pitavastatin Tablets, 1 mg NDC 70771-1784-9 Bottle of 90 tablets Rx only Pitavastatin Tablets, 2 mg NDC 70771-1785-9 Bottle of 90 tablets Rx only Pitavastatin Tablets, 4 mg NDC 70771-1786-9 Bottle of 90 tablets Rx only 1 mg label 2 mg label 4 mg label

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