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Serving leading biopharmaceutical companies globally:

Harvard Business School
Express Scripts
Queensland Health
Daiichi Sankyo

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075440

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NDA 075440 describes HALOPERIDOL DECANOATE, which is a drug marketed by Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Mylan Labs Ltd, Sandoz Inc, Teva Pharms Usa, and West-ward Pharms Int, and is included in eight NDAs. It is available from seven 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. Nine suppliers are listed for this compound. Additional details are available on the haloperidol decanoate profile page.
Summary for 075440
Applicant:Mylan Labs Ltd
Ingredient:haloperidol decanoate
Formulation / Manufacturing:see details
Pharmacology for NDA: 075440
Suppliers and Packaging for NDA: 075440
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HALOPERIDOL DECANOATE haloperidol decanoate INJECTABLE;INJECTION 075440 ANDA Amneal-Agila, LLC 53150-415 53150-415-10 10 VIAL, SINGLE-DOSE in 1 CARTON (53150-415-10) > 1 mL in 1 VIAL, SINGLE-DOSE (53150-415-01)
HALOPERIDOL DECANOATE haloperidol decanoate INJECTABLE;INJECTION 075440 ANDA Amneal-Agila, LLC 53150-422 53150-422-05 5 VIAL, MULTI-DOSE in 1 CARTON (53150-422-05) > 5 mL in 1 VIAL, MULTI-DOSE (53150-422-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/ML
Approval Date:Feb 28, 2000TE:AORLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/ML
Approval Date:Feb 28, 2000TE:AORLD:No

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Serving leading biopharmaceutical companies globally:

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