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  • Duloxetine DULOXETINE HYDROCHLORIDE 60 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

20230921

Version

5

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 385;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 386;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 387;60;mg

Application Number

ANDA090728

Brand Name

Duloxetine

Generic Name

Duloxetine

Product Ndc

70771-1346

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1344-3 Duloxetine Delayed-release Capsules, 20mg 30 Capsules Rx only NDC 70771-1345-3 Duloxetine Delayed-release Capsules, 30mg 30 Capsules Rx only NDC 70771-1346-3 Duloxetine Delayed-release Capsules, 60mg 30 Capsules Rx only Duloxetine delayed-release capsules Duloxetine delayed-release capsules Duloxetine delayed-release capsules

Spl Medguide

Manufactured by: Cadila Healthcare Ltd. India.

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