This site is intended for healthcare professionals
Abstract digital waveforms in blue and purple
FDA Drug information

CLOBAZAM

Read time: 1 mins
Marketing start date: 23 Dec 2024

Summary of product characteristics


Effective Time

20230920

Version

5

Spl Product Data Elements

CLOBAZAM CLOBAZAM CLOBAZAM CLOBAZAM STARCH, CORN LACTOSE MONOHYDRATE MAGNESIUM STEARATE SILICON DIOXIDE TALC OFF-WHITE MODIFIED CAPSULE 13;25 CLOBAZAM CLOBAZAM CLOBAZAM CLOBAZAM STARCH, CORN LACTOSE MONOHYDRATE MAGNESIUM STEARATE SILICON DIOXIDE TALC OFF-WHITE MODIFIED CAPSULE 13;26

Application Number

ANDA211449

Brand Name

CLOBAZAM

Generic Name

CLOBAZAM

Product Ndc

70771-1440

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1440-1 Clobazam Tablets, 10 mg 100 Tablets Rx only Zydus NDC 70771-1441-1 Clobazam Tablets, 20 mg 100 Tablets Rx only Zydus Clobazam tablets- Clobazam Tablets

Spl Medguide

SPL MEDGUIDE

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.

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.