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FDA Drug information

Droxidopa

Read time: 1 mins
Marketing start date: 29 Apr 2024
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Summary of product characteristics


Effective Time

20220825

Version

2

Spl Product Data Elements

Droxidopa Droxidopa DROXIDOPA DROXIDOPA FD&C BLUE NO. 1 FD&C RED NO. 40 FERROSOFERRIC OXIDE GELATIN MAGNESIUM STEARATE MANNITOL POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE WATER opaque blue cap opaque white body 1389 Droxidopa Droxidopa DROXIDOPA DROXIDOPA FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GELATIN MAGNESIUM STEARATE MANNITOL POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE WATER opaque yellow cap opaque white body 1390 Droxidopa Droxidopa DROXIDOPA DROXIDOPA FD&C BLUE NO. 1 FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GELATIN MAGNESIUM STEARATE MANNITOL POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE WATER opaque green cap opaque white body 1391

Application Number

ANDA211818

Brand Name

Droxidopa

Generic Name

Droxidopa

Product Ndc

70771-1609

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1609-9 Droxidopa Capsules, 100 mg 90 Capsules Rx only NDC 70771-1610-9 Droxidopa Capsules, 200 mg 90 Capsules Rx only NDC 70771-1611-9 Droxidopa Capsules, 300 mg 90 Capsules Rx only Droxi-100mg-image droxi-200mg-image Droxi-300mg-image

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