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FDA Drug information

ATAZANAVIR

Read time: 1 mins
Marketing start date: 28 Apr 2024
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Summary of product characteristics


Effective Time

20221013

Version

2

Spl Product Data Elements

ATAZANAVIR ATAZANAVIR ATAZANAVIR SULFATE ATAZANAVIR LACTOSE MONOHYDRATE CELLULOSE, MICROCRYSTALLINE CROSPOVIDONE TALC MAGNESIUM STEARATE TITANIUM DIOXIDE GELATIN FD&C BLUE NO. 1 D&C RED NO. 28 FD&C RED NO. 40 D&C YELLOW NO. 10 FERROSOFERRIC OXIDE BUTYL ALCOHOL ALCOHOL ISOPROPYL ALCOHOL POTASSIUM HYDROXIDE PROPYLENE GLYCOL WATER SHELLAC AMMONIA opaque blue grey opaque 1050 ATAZANAVIR ATAZANAVIR ATAZANAVIR SULFATE ATAZANAVIR LACTOSE MONOHYDRATE CELLULOSE, MICROCRYSTALLINE CROSPOVIDONE TALC MAGNESIUM STEARATE TITANIUM DIOXIDE GELATIN FD&C BLUE NO. 1 D&C RED NO. 28 FERROSOFERRIC OXIDE BUTYL ALCOHOL ALCOHOL ISOPROPYL ALCOHOL POTASSIUM HYDROXIDE PROPYLENE GLYCOL WATER SHELLAC AMMONIA opaque blue blue opaque 1051 ATAZANAVIR ATAZANAVIR ATAZANAVIR SULFATE ATAZANAVIR LACTOSE MONOHYDRATE CELLULOSE, MICROCRYSTALLINE CROSPOVIDONE TALC MAGNESIUM STEARATE TITANIUM DIOXIDE GELATIN FD&C BLUE NO. 1 D&C RED NO. 28 FERROSOFERRIC OXIDE BUTYL ALCOHOL ALCOHOL ISOPROPYL ALCOHOL POTASSIUM HYDROXIDE PROPYLENE GLYCOL WATER SHELLAC AMMONIA FERRIC OXIDE YELLOW FERRIC OXIDE RED orange opaque blue opaque 1052

Application Number

ANDA210575

Brand Name

ATAZANAVIR

Generic Name

ATAZANAVIR

Product Ndc

70771-1593

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1591-6 in bottle of 60 Capsules Atazanavir Capsules, 150 mg Rx only 60 Capsules NDC 70771-1592-6 in bottle of 60 Capsules Atazanavir Capsules, 200 mg Rx only 60 Capsules NDC 70771-1593-3 in bottle of 30 Capsules Atazanavir Capsules, 300 mg Rx only 30 Capsules 150 mg label 200 mg label 300 mg label

Drug section

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