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FDA Drug information

Doxepin Hydrochloride

Read time: 1 mins
Marketing start date: 12 Jan 2025
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Summary of product characteristics


Effective Time

20240703

Version

1

Spl Product Data Elements

Doxepin Hydrochloride Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE DOXEPIN ALCOHOL AMMONIA BUTYL ALCOHOL FD&C BLUE NO. 1 FD&C RED NO. 40 FERROSOFERRIC OXIDE GELATIN ISOPROPYL ALCOHOL MAGNESIUM STEARATE POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE WATER OPAQUE WHITE BODY OPAQUE BLUE CAP 1301

Application Number

ANDA210140

Brand Name

Doxepin Hydrochloride

Generic Name

Doxepin Hydrochloride

Product Ndc

70771-1390

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1390-7 Doxepin Hydrochloride Capsules USP, 150 mg Rx only 50 Capsules 150 mg label

Drug section

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