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Last Updated: August 2, 2021

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Details for New Drug Application (NDA): 211180


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NDA 211180 describes HALOPERIDOL DECANOATE, which is a drug marketed by Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Mylan Labs Ltd, Sandoz Inc, Somerset Theraps Llc, Teva Pharms Usa, West-ward Pharms Int, and Zydus Pharms, and is included in ten NDAs. It is available from nine suppliers. Additional details are available on the HALOPERIDOL DECANOATE profile page.

The generic ingredient in HALOPERIDOL DECANOATE is haloperidol decanoate. There are twenty drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the haloperidol decanoate profile page.
Summary for 211180
Tradename:HALOPERIDOL DECANOATE
Applicant:Zydus Pharms
Ingredient:haloperidol decanoate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 211180
Suppliers and Packaging for NDA: 211180
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HALOPERIDOL DECANOATE haloperidol decanoate INJECTABLE;INJECTION 211180 ANDA Zydus Pharmaceuticals (USA) Inc. 70710-1461 70710-1461-6 10 VIAL, SINGLE-DOSE in 1 CARTON (70710-1461-6) > 1 mL in 1 VIAL, SINGLE-DOSE (70710-1461-1)
HALOPERIDOL DECANOATE haloperidol decanoate INJECTABLE;INJECTION 211180 ANDA Zydus Pharmaceuticals (USA) Inc. 70710-1461 70710-1461-9 3 VIAL, SINGLE-DOSE in 1 CARTON (70710-1461-9) > 1 mL in 1 VIAL, SINGLE-DOSE (70710-1461-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/ML
Approval Date:Oct 22, 2019TE:AORLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/ML
Approval Date:Oct 22, 2019TE:AORLD:No

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