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  • Doxepin DOXEPIN HYDROCHLORIDE 3 mg/1 Zydus Lifesciences Limited
FDA Drug information

Doxepin

Read time: 1 mins
Marketing start date: 27 Apr 2024

Summary of product characteristics


Effective Time

20230918

Version

1

Spl Product Data Elements

doxepin doxepin DOXEPIN HYDROCHLORIDE DOXEPIN FD&C BLUE NO. 1 LACTOSE MONOHYDRATE MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN TALC LIGHT BLUE ROUND 393 doxepin doxepin DOXEPIN HYDROCHLORIDE DOXEPIN D&C YELLOW NO. 10 FD&C BLUE NO. 1 LACTOSE MONOHYDRATE MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO TALC STARCH, CORN LIGHT GREEN ROUND 394

Application Number

ANDA202761

Brand Name

Doxepin

Generic Name

doxepin

Product Ndc

70771-1528

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1528-5 in bottle of 500 tablets Doxepin Tablets, 3 mg Rx only 500 tablets NDC 70771-1529-5 in bottle of 500 tablets Doxepin Tablets, 6 mg Rx only 500 tablets 3 mg label 6 mg label

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