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FDA Drug information

Haloperidol decanoate

Read time: 1 mins
Marketing start date: 14 Nov 2024
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Summary of product characteristics


Effective Time

20230901

Version

1

Spl Product Data Elements

Haloperidol decanoate Haloperidol decanoate HALOPERIDOL DECANOATE HALOPERIDOL SESAME OIL BENZYL ALCOHOL Haloperidol decanoate Haloperidol decanoate HALOPERIDOL DECANOATE HALOPERIDOL SESAME OIL BENZYL ALCOHOL Haloperidol decanoate Haloperidol decanoate HALOPERIDOL DECANOATE HALOPERIDOL SESAME OIL BENZYL ALCOHOL Haloperidol decanoate Haloperidol decanoate HALOPERIDOL DECANOATE HALOPERIDOL SESAME OIL BENZYL ALCOHOL

Application Number

ANDA211180

Brand Name

Haloperidol decanoate

Generic Name

Haloperidol decanoate

Product Ndc

70771-1851

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAMUSCULAR

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 50 mg/mL Carton (3 vials per carton) NDC 70771-1851-9 Haloperidol Decanoate Injection 50 mg/mL* For Intramuscular Use Only 3 X 1 mL Single-Dose Vials Sterile Rx only 250 mg/5 mL (50 mg/mL) Carton (1 vial per carton) NDC 70771-1852-1 Haloperidol Decanoate Injection 250 mg/5 mL* (50 mg/mL) For Intramuscular Use Only 5 mL Multiple-Dose Vial Sterile Rx only 100 mg/mL Carton (1 vial per carton) NDC 70771-1853-1 Haloperidol Decanoate Injection 100 mg/mL* For Intramuscular Use Only 1 mL Single-Dose Vial Sterile Rx only 500 mg/5 mL (100 mg/mL) Carton (1 vial per carton) NDC 70771-1854-1 Haloperidol Decanoate Injection 500 mg/5 mL* (100 mg/mL) For Intramuscular Use Only 5 mL Multiple-Dose Vial Sterile Rx only 50 mg per mL carton label 250 mg per 5 mL carton label 100 mg per mL carton label 500 mg per 5 mL carton label

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