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

Clomipramine Hydrochloride

Read time: 1 mins
Marketing start date: 23 Nov 2024
...
 

Summary of product characteristics


Effective Time

20230921

Version

6

Spl Product Data Elements

Clomipramine Hydrochloride Clomipramine Hydrochloride CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE ALCOHOL AMMONIA BUTYL ALCOHOL CELLULOSE, MICROCRYSTALLINE D&C RED NO. 28 D&C RED NO. 33 D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 FERROSOFERRIC OXIDE GELATIN ISOPROPYL ALCOHOL MAGNESIUM STEARATE POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE WATER OPAQUE PINK CAP OPAQUE LIGHT PINK BODY CAPSULE 1065 Clomipramine Hydrochloride Clomipramine Hydrochloride CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE ALCOHOL AMMONIA BUTYL ALCOHOL CELLULOSE, MICROCRYSTALLINE D&C RED NO. 33 FD&C RED NO. 40 FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GELATIN ISOPROPYL ALCOHOL MAGNESIUM STEARATE POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE WATER OPAQUE YELLOW CAP OPAQUE LIGHT PINK BODY CAPSULE 1066 Clomipramine Hydrochloride Clomipramine Hydrochloride CLOMIPRAMINE HYDROCHLORIDE CLOMIPRAMINE ALCOHOL AMMONIA BUTYL ALCOHOL CELLULOSE, MICROCRYSTALLINE D&C RED NO. 28 D&C RED NO. 33 FD&C BLUE NO. 1 FD&C RED NO. 40 FERROSOFERRIC OXIDE GELATIN ISOPROPYL ALCOHOL MAGNESIUM STEARATE POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE WATER OPAQUE DARK PINK CAP OPAQUE LIGHT PINK BODY CAPSULE 1067

Application Number

ANDA208961

Brand Name

Clomipramine Hydrochloride

Generic Name

Clomipramine Hydrochloride

Product Ndc

70771-1014

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1012-1 Clomipramine Hydrochloride Capsules USP, 25 mg R x only 100 Capsules NDC 70771-1013-1 Clomipramine Hydrochloride Capsules USP, 50 mg R x only 100 Capsules NDC 70771-1014-1 Clomipramine Hydrochloride Capsules USP, 75 mg R x only 100 Capsules Clomipramine Hydrochloride Capsules, USP Clomipramine Hydrochloride Capsules, USP Clomipramine Hydrochloride Capsules, USP

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.