This site is intended for healthcare professionals
Abstract digital waveforms in blue and purple
  • Home
  • /
  • Drugs
  • /
  • P
  • /
  • PAROXETINE
  • /
  • Paroxetine PAROXETINE HYDROCHLORIDE ANHYDROUS 40 mg/1 Zydus Lifesciences Limited
FDA Drug information

Paroxetine

Read time: 1 mins
Marketing start date: 21 Dec 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

65841-601

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

Drug section

CME banner

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Click here to view

Disclaimer

The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

Medthority offers the whole library of PI documents from the FDA. Medthority will not be held liable for explicit or implicit errors, or missing data.

Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.