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  • Bupropion BUPROPION HYDROCHLORIDE 300 mg/1 Zydus Lifesciences Limited
FDA Drug information

Bupropion

Read time: 1 mins
Marketing start date: 12 Nov 2024
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Summary of product characteristics


Effective Time

20230920

Version

10

Spl Product Data Elements

bupropion bupropion BUPROPION HYDROCHLORIDE BUPROPION HYPROMELLOSES MAGNESIUM STEARATE METHACRYLIC ACID POLYETHYLENE GLYCOL, UNSPECIFIED TRIETHYL CITRATE POVIDONE ETHYLCELLULOSES SILICON DIOXIDE BUTYL ALCOHOL FERROSOFERRIC OXIDE ISOPROPYL ALCOHOL PROPYLENE GLYCOL SHELLAC AMMONIA CREAMY WHITE TO PALE YELLOW ROUND 354 bupropion bupropion BUPROPION HYDROCHLORIDE BUPROPION HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED METHACRYLIC ACID TRIETHYL CITRATE POVIDONE ETHYLCELLULOSES SILICON DIOXIDE BUTYL ALCOHOL FERROSOFERRIC OXIDE ISOPROPYL ALCOHOL PROPYLENE GLYCOL SHELLAC AMMONIA CREAMY WHITE TO PALE YELLOW ROUND 353

Application Number

ANDA201567

Brand Name

Bupropion

Generic Name

bupropion

Product Ndc

65841-780

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-780-05 Bupropion Hydrochloride Extended-release Tablets USP (XL), 300 mg 500 Tablets Rx only NDC 65841-836-05 Bupropion Hydrochloride Extended-release Tablets USP (XL), 150 mg 500 Tablets Rx only Bupropion hydrochloride extended-release tablets, USP (XL) label

Spl Medguide

Manufactured by: Cadila Healthcare Ltd. India.

Drug section

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