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FDA Drug information

Clomipramine Hydrochloride

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

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