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  • Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 Zydus Lifesciences Limited
FDA Drug information

Duloxetine

Read time: 1 mins
Marketing start date: 23 Dec 2024
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Summary of product characteristics


Effective Time

20221013

Version

6

Spl Product Data Elements

Duloxetine Duloxetine DULOXETINE HYDROCHLORIDE DULOXETINE ALCOHOL AMMONIA BUTYL ALCOHOL D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C YELLOW NO. 6 FERRIC OXIDE YELLOW GELATIN HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) HYPROMELLOSES ISOPROPYL ALCOHOL PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE STARCH, CORN SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE GREEN WHITE CAPSULE 241;20;mg Duloxetine Duloxetine DULOXETINE HYDROCHLORIDE DULOXETINE FD&C BLUE NO. 1 GELATIN HYPROMELLOSES HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) SODIUM LAURYL SULFATE SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE D&C YELLOW NO. 10 FD&C RED NO. 40 FD&C YELLOW NO. 6 BUTYL ALCOHOL ALCOHOL ISOPROPYL ALCOHOL PROPYLENE GLYCOL SHELLAC AMMONIA FERRIC OXIDE YELLOW STARCH, CORN BLUE GREEN CAPSULE 242;30;mg Duloxetine Duloxetine DULOXETINE HYDROCHLORIDE DULOXETINE FD&C BLUE NO. 1 GELATIN HYPROMELLOSES HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) SODIUM LAURYL SULFATE SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE FD&C RED NO. 40 BUTYL ALCOHOL ALCOHOL ISOPROPYL ALCOHOL PROPYLENE GLYCOL SHELLAC AMMONIA FERRIC OXIDE YELLOW STARCH, CORN BLUE WHITE CAPSULE 243;60;mg

Application Number

ANDA090739

Brand Name

Duloxetine

Generic Name

Duloxetine

Product Ndc

65841-800

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-799-16 Duloxetine Delayed-release Capsules, 20mg 90 Capsules Rx only NDC 65841-800-16 Duloxetine Delayed-release Capsules, 30mg 90 Capsules Rx only NDC 65841-801-16 Duloxetine Delayed-release Capsules, 60mg 90 Capsules Rx only Duloxetine delayed-release capsules Duloxetine delayed-release capsules Duloxetine delayed-release capsules

Spl Medguide

Manufactured by: Cadila Healthcare Ltd. India

Drug section

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