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- Haloperidol decanoate HALOPERIDOL DECANOATE 100 mg/mL Zydus Lifesciences Limited
Haloperidol decanoate
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- HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE 100 mg/mL REMEDYREPACK INC.
- Haloperidol decanoate HALOPERIDOL DECANOATE 100 mg/mL Zydus Lifesciences Limited
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
70771-1854
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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