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  • Paroxetine PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Zydus Lifesciences Limited
FDA Drug information

Paroxetine

Read time: 1 mins
Marketing start date: 24 Jul 2024

Summary of product characteristics


Effective Time

20221031

Version

11

Spl Product Data Elements

Paroxetine Paroxetine Hydrochloride PAROXETINE HYDROCHLORIDE ANHYDROUS PAROXETINE PAROXETINE ANHYDROUS DIBASIC CALCIUM PHOSPHATE ANHYDROUS LACTOSE HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL 6000 SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE TALC TITANIUM DIOXIDE WHITE TO OFF-WHITE ROUND ZC;15 Paroxetine Paroxetine Hydrochloride PAROXETINE HYDROCHLORIDE ANHYDROUS PAROXETINE PAROXETINE ANHYDROUS DIBASIC CALCIUM PHOSPHATE ANHYDROUS LACTOSE HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL 6000 SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE TALC TITANIUM DIOXIDE WHITE TO OFF-WHITE ROUND ZC;16 Paroxetine Paroxetine Hydrochloride PAROXETINE HYDROCHLORIDE ANHYDROUS PAROXETINE PAROXETINE ANHYDROUS DIBASIC CALCIUM PHOSPHATE ANHYDROUS LACTOSE HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL 6000 SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE TALC TITANIUM DIOXIDE WHITE TO OFF-WHITE ROUND ZC17 Paroxetine Paroxetine Hydrochloride PAROXETINE HYDROCHLORIDE ANHYDROUS PAROXETINE PAROXETINE ANHYDROUS DIBASIC CALCIUM PHOSPHATE ANHYDROUS LACTOSE HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL 6000 SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE TALC TITANIUM DIOXIDE WHITE TO OFF-WHITE ROUND ZC18

Application Number

ANDA077584

Brand Name

Paroxetine

Generic Name

Paroxetine Hydrochloride

Product Ndc

65841-097

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-097-05 in pack count of 500 tablets Paroxetine Tablets USP, 10 mg R x only 500 tablets NDC 65841-098-16 in pack count of 90 tablets Paroxetine Tablets USP, 20 mg R x only 90 tablets NDC 65841-099-10 in pack count of 1000 tablets Paroxetine Tablets USP, 30 mg R x only 1000 tablets NDC 65841-601-06 in pack count of 30 tablets Paroxetine Tablets USP, 40 mg R x only 30 tablets Paroxetine tablets, 10 mg Paroxetine tablets, 20 mg Paroxetine tablets, 30 mg Paroxetine tablets, 40 mg

Spl Medguide

SPL MEDGUIDE

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